MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x "My Therapy" Patient Therapy Application Software, Model Number A52300
- Company
- Medtronic Neuromodulation
- Recall Initiated
- February 28, 2022
- Posted
- April 22, 2022
- Recall Number
- Z-0998-2022
- Quantity
- 1005 units
- Firm Location
- Minneapolis, MN
Reason for Recall
There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed.
Distribution
US Nationwide distribution in the states of FL, IL, WI, TX, CA, ND, NC, KY, AR, MO, MN, OH, CO, KS, MS, SC, LA, WA, PA, IN, SD, MI, WV, AL, GA, TN, VA, IA.
Lot / Code Info
a) Model Numbers: 1) TH90Q01, UDI-Device Identifier (GTIN/UPN) 00763000582470, Serial Numbers: NPF0000074, NPF0000075, NPF0000096, NPF0000097, NPF0000109, NPF0000197, NPF0000238, NPF0000263, NPF0000264, NPF0000270, NPF0000271, NPF0000284, NPF0000292, NPF0000379, NPF0000414, NPF0000422, NPF0000440, NPF0000458, NPF0000463, NPF0000480, NPF0000501, NPF0000515, NPF0000516, NPF0000517, NPF0000519, NPF0000537, NPF0000555, NPF0000618, NPF0000656, NPF0000691, NPF0000715, NPF0000784, NPF0000786, NPF0000828, NPF0000889, NPF0000908, NPF0000913, NPF0000915, NPF0000930, NPF0000931, NPF0001006, NPF0001045, NPF0001057, NPF0001058, NPF0001059, NPF0001060, NPF0001130, NPF0001135, NPF0001136, NPF0001154, NPF0001199, NPF0001267, NPF0001391, NPF0001403, NPF0001458, NPF0001485, NPF0001492, NPF0001493, NPF0001498, NPF0001502, NPF0001511, NPF0001620, NPF0001674, NPF0001713, NPF0001716, NPF0001758, NPF0001797, NPF0001824, NPF0001841, NPF0001868, NPF0001879, NPF0001893, NPF0001894, NPF0001900, NPF0001928, NPF0001931, NPF0002020, NPF0002025, NPF0002077, NPF0002078, NPF0002079, NPF0002102, NPF0002105, NPF0002117, NPF0002127, NPF0000060, NPF0000061, NPF0000063, NPF0000070, NPF0000099, NPF0000100, NPF0000116, NPF0000160, NPF0000291, NPF0000330, NPF0000465, NPF0000476, NPF0000477, NPF0000613, NPF0000614, NPF0000615, NPF0000617, NPF0000619, NPF0000654, NPF0000655, NPF0000690, NPF0000709, NPF0000711, NPF0000755, NPF0000756, NPF0000779, NPF0000804, NPF0000807, NPF0000823, NPF0000871, NPF0000880, NPF0000907, NPF0000977, NPF0000983, NPF0001000, NPF0001119, NPF0001145, NPF0001152, NPF0001158, NPF0001161, NPF0001188, NPF0001192, NPF0001208, NPF0001387, NPF0001456, NPF0001516, NPF0001554, NPF0001759, NPF0001781, NPF0002048, NPF0002076, NPF0002369, NPF0003037, NPF0003054, NPF0003386, NPF0000186, NPF0000222, NPF0000269, NPF0000289, NPF0000295, NPF0000296, NPF0000310, NPF0000319, NPF0000341, NPF0000766, NPF0001194, NPF0001209, NPF0001210, NPF0001213, NPF0001268, NPF0001278, NPF0001281, NPF0001291, NPF0001295, NPF0001319, NPF0001345, NPF0001357, NPF0001361, NPF0001362, NPF0001390, NPF0001420, NPF0001425, NPF0001555, NPF0001565, NPF0001618, NPF0001776, NPF0001898, NPF0001975, NPF0001984, NPF0002064, NPF0002080, NPF0002084, NPF0002085, NPF0002090, NPF0002144, NPF0002216, NPF0002229, NPF0002608, NPF0002622, NPF0002646, NPF0001820, NPF0001823, NPF0000064, NPF0000073, NPF0000085, NPF0000086, NPF0000088, NPF0000089, NPF0000091, NPF0000092, NPF0000095, NPF0000102, NPF0000103, NPF0000105, NPF0000107, NPF0000110, NPF0000117, NPF0000129, NPF0000130, NPF0000131, NPF0000150, NPF0000156, NPF0000158, NPF0000161, NPF0000172, NPF0000173, NPF0000174, NPF0000175, NPF0000176, NPF0000178, NPF0000179, NPF0000180, NPF0000181, NPF0000187, NPF0000192, NPF0000196, NPF0000198, NPF0000199, NPF0000203, NPF0000209, NPF0000210, NPF0000211, NPF0000212, NPF0000213, NPF0000214, NPF0000218, NPF0000221, NPF0000223, NPF0000234, NPF0000237, NPF0000244, NPF0000245, NPF0000246, NPF0000247, NPF0000248, NPF0000250, NPF0000256, NPF0000260, NPF0000266, NPF0000272, NPF0000277, NPF0000294, NPF0000298, NPF0000300, NPF0000301, NPF0000302, NPF0000303, NPF0000305, NPF0000309, NPF0000311, NPF0000312, NPF0000313, NPF0000320, NPF0000336, NPF0000340, NPF0000342, NPF0000345, NPF0000350, NPF0000353, NPF0000354, NPF0000357, NPF0000358, NPF0000364, NPF0000368, NPF0000369, NPF0000389, NPF0000393, NPF0000395, NPF0000397, NPF0000403, NPF0000404, NPF0000436, NPF0000438, NPF0000442, NPF0000447, NPF0000454, NPF0000459, NPF0000460, NPF0000461, NPF0000462, NPF0000471, NPF0000488, NPF0000497, NPF0000514, NPF0000518, NPF0000520, NPF0000521, NPF0000522, NPF0000524, NPF0000525, NPF0000526, NPF0000528, NPF0000530, NPF0000532, NPF0000539, NPF0000561, NPF0000564, NPF0000567, NPF0000568, NPF0000581, NPF0000587, NPF0000588, NPF0000606, NPF0000621, NPF0000623, NPF0000626, NPF0000638, NPF0000639, NPF0000643, NPF0000645, NPF0000650, NPF0000653, NPF0000657, NPF0000659, NPF0000660, NPF0000661, NPF0000676, NPF0000680, NPF0000683, NPF0000684, NPF0000686, NPF0000687, NPF0000689, NPF0000694, NPF0000704, NPF0000707, NPF0000712, NPF0000713, NPF0000714, NPF0000717, NPF0000720, NPF0000724, NPF0000728, NPF0000732, NPF0000737, NPF0000748, NPF0000750, NPF0000754, NPF0000758, NPF0000759, NPF0000761, NPF0000762, NPF0000763, NPF0000772, NPF0000775, NPF0000781, NPF0000783, NPF0000789, NPF0000794, NPF0000798, NPF0000805, NPF0000808, NPF0000809, NPF0000811, NPF0000812, NPF0000822, NPF0000824, NPF0000825, NPF0000826, NPF0000829, NPF0000830, NPF0000831, NPF0000832, NPF0000838, NPF0000840, NPF0000844, NPF0000846, NPF0000849, NPF0000863, NPF0000864, NPF0000865, NPF0000866, NPF0000868, NPF0000869, NPF0000870, NPF0000872, NPF0000882, NPF0000883, NPF0000886, NPF0000887, NPF0000890, NPF0000891, NPF0000892, NPF0000895, NPF0000903, NPF0000904, NPF0000906, NPF0000909, NPF0000911, NPF0000916, NPF0000918, NPF0000919, NPF0000920, NPF0000921, NPF0000923, NPF0000926, NPF0000928, NPF0000935, NPF0000948, NPF0000954, NPF0000959, NPF0000960, NPF0000962, NPF0000963, NPF0000965, NPF0000979, NPF0000980, NPF0000982, NPF0000993, NPF0000997, NPF0001001, NPF0001010, NPF0001018, NPF0001019, NPF0001024, NPF0001029, NPF0001031, NPF0001039, NPF0001040, NPF0001042, NPF0001044, NPF0001047, NPF0001049, NPF0001061, NPF0001062, NPF0001064, NPF0001067, NPF0001069, NPF0001070, NPF0001071, NPF0001072, NPF0001073, NPF0001074, NPF0001075, NPF0001076, NPF0001077, NPF0001078, NPF0001079, NPF0001080, NPF0001081, NPF0001083, NPF0001089, NPF0001090, NPF0001096, NPF0001099, NPF0001100, NPF0001105, NPF0001113, NPF0001114, NPF0001127, NPF0001131, NPF0001134, NPF0001148, NPF0001149, NPF0001150, NPF0001151, NPF0001156, NPF0001175, NPF0001178, NPF0001179, NPF0001180, NPF0001181, NPF0001182, NPF0001183, NPF0001184, NPF0001185, NPF0001187, NPF0001189, NPF0001190, NPF0001195, NPF0001205, NPF0001212, NPF0001240, NPF0001260, NPF0001264, NPF0001270, NPF0001273, NPF0001275, NPF0001277, NPF0001283, NPF0001289, NPF0001293, NPF0001294, NPF0001299, NPF0001316, NPF0001321, NPF0001327, NPF0001334, NPF0001339, NPF0001341, NPF0001342, NPF0001347, NPF0001359, NPF0001360, NPF0001366, NPF0001368, NPF0001370, NPF0001374, NPF0001378, NPF0001385, NPF0001393, NPF0001397, NPF0001398, NPF0001406, NPF0001407, NPF0001412, NPF0001413, NPF0001422, NPF0001423, NPF0001424, NPF0001426, NPF0001428, NPF0001429, NPF0001430, NPF0001431, NPF0001432, NPF0001433, NPF0001434, NPF0001436, NPF0001437, NPF0001445, NPF0001451, NPF0001452, NPF0001454, NPF0001455, NPF0001460, NPF0001461, NPF0001463, NPF0001464, NPF0001466, NPF0001467, NPF0001481, NPF0001484, NPF0001496, NPF0001499, NPF0001500, NPF0001503, NPF0001504, NPF0001508, NPF0001510, NPF0001513, NPF0001514, NPF0001520, NPF0001521, NPF0001522, NPF0001523, NPF0001526, NPF0001527, NPF0001528, NPF0001530, NPF0001532, NPF0001535, NPF0001536, NPF0001539, NPF0001540, NPF0001543, NPF0001550, NPF0001551, NPF0001556, NPF0001560, NPF0001562, NPF0001563, NPF0001570, NPF0001574, NPF0001576, NPF0001577, NPF0001578, NPF0001579, NPF0001585, NPF0001588, NPF0001604, NPF0001608, NPF0001621, NPF0001625, NPF0001626, NPF0001627, NPF0001628, NPF0001629, NPF0001633, NPF0001635, NPF0001636, NPF0001638, NPF0001645, NPF0001649, NPF0001650, NPF0001652, NPF0001653, NPF0001654, NPF0001656, NPF0001657, NPF0001668, NPF0001671, NPF0001672, NPF0001673, NPF0001681, NPF0001684, NPF0001690, NPF0001691, NPF0001692, NPF0001694, NPF0001698, NPF0001700, NPF0001703, NPF0001706, NPF0001707, NPF0001710, NPF0001714, NPF0001715, NPF0001718, NPF0001735, NPF0001741, NPF0001745, NPF0001747, NPF0001749, NPF0001750, NPF0001754, NPF0001755, NPF0001762, NPF0001763, NPF0001766, NPF0001767, NPF0001769, NPF0001775, NPF0001786, NPF0001789, NPF0001800, NPF0001803, NPF0001826, NPF0001837, NPF0001842, NPF0001843, NPF0001847, NPF0001857, NPF0001859, NPF0001876, NPF0001877, NPF0001880, NPF0001884, NPF0001886, NPF0001889, NPF0001892, NPF0001895, NPF0001906, NPF0001917, NPF0001929, NPF0001932, NPF0001934, NPF0001936, NPF0001937, NPF0001939, NPF0001940, NPF0001941, NPF0001942, NPF0001943, NPF0001946, NPF0001948, NPF0001949, NPF0001950, NPF0001951, NPF0001952, NPF0001954, NPF0001956, NPF0001957, NPF0001959, NPF0001960, NPF0001962, NPF0001970, NPF0001974, NPF0001976, NPF0001978, NPF0001981, NPF0001982, NPF0001985, NPF0001987, NPF0001988, NPF0001996, NPF0001997, NPF0001998, NPF0001999, NPF0002000, NPF0002004, NPF0002006, NPF0002008, NPF0002010, NPF0002011, NPF0002014, NPF0002015, NPF0002019, NPF0002022, NPF0002026, NPF0002034, NPF0002038, NPF0002044, NPF0002046, NPF0002049, NPF0002051, NPF0002054, NPF0002062, NPF0002071, NPF0002074, NPF0002096, NPF0002097, NPF0002098, NPF0002099, NPF0002100, NPF0002101, NPF0002106, NPF0002109, NPF0002110, NPF0002111, NPF0002113, NPF0002114, NPF0002124, NPF0002125, NPF0002131, NPF0002132, NPF0002138, NPF0002140, NPF0002142, NPF0002146, NPF0002150, NPF0002152, NPF0002154, NPF0002155, NPF0002156, NPF0002158, NPF0002163, NPF0002165, NPF0002166, NPF0002169, NPF0002172, NPF0002173, NPF0002178, NPF0002182, NPF0002183, NPF0002186, NPF0002187, NPF0002194, NPF0002196, NPF0002210, NPF0002219, NPF0002224, NPF0002230, NPF0002236, NPF0002238, NPF0002250, NPF0002256, NPF0002266, NPF0002271, NPF0002286, NPF0002288, NPF0002300, NPF0002314, NPF0002317, NPF0002327, NPF0002328, NPF0002333, NPF0002346, NPF0002348, NPF0002351, NPF0002352, NPF0002355, NPF0002361, NPF0002364, NPF0002378, NPF0002380, NPF0002381, NPF0002384, NPF0002399, NPF0002405, NPF0002406, NPF0002408, NPF0002411, NPF0002414, NPF0002415, NPF0002422, NPF0002423, NPF0002425, NPF0002432, NPF0002456, NPF0002459, NPF0002462, NPF0002463, NPF0002471, NPF0002484, NPF0002485, NPF0002486, NPF0002490, NPF0002497, NPF0002502, NPF0002506, NPF0002509, NPF0002548, NPF0002572, NPF0002573, NPF0002577, NPF0002581, NPF0002582, NPF0002584, NPF0002586, NPF0002610, NPF0002612, NPF0002619, NPF0002621, NPF0002623, NPF0002624, NPF0002626, NPF0002632, NPF0002641, NPF0002642, NPF0002647, NPF0002649, NPF0002655, NPF0002658, NPF0002660, NPF0002674, NPF0002682, NPF0002685, NPF0002686, NPF0002691, NPF0002694, NPF0002721, NPF0002741, NPF0002753, NPF0002756, NPF0002759, NPF0002760, NPF0002761, NPF0002762, NPF0002764, NPF0002765, NPF0002766, NPF0002767, NPF0002768, NPF0002770, NPF0002796, NPF0002797, NPF0002800, NPF0002803, NPF0002816, NPF0002831, NPF0002834, NPF0002836, NPF0002839, NPF0002840, NPF0002843, NPF0002844, NPF0002848, NPF0002849, NPF0002851, NPF0002852, NPF0002853, NPF0002854, NPF0002856, NPF0002858, NPF0002859, NPF0002864, NPF0002866, NPF0002868, NPF0002869, NPF0002871, NPF0002874, NPF0002875, NPF0002877, NPF0002878, NPF0002879, NPF0002881, NPF0002882, NPF0002883, NPF0002884, NPF0002885, NPF0002886, NPF0002887, NPF0002889, NPF0002895, NPF0002897, NPF0002911, NPF0002912, NPF0002913, NPF0002915, NPF0002916, NPF0002917, NPF0002918, NPF0002919, NPF0002922, NPF0002924, NPF0002927, NPF0002928, NPF0002929, NPF0002932, NPF0002933, NPF0002936, NPF0002938, NPF0002944, NPF0002952, NPF0002953, NPF0002954, NPF0002955, NPF0002958, NPF0002959, NPF0002961, NPF0002962, NPF0002964, NPF0002965, NPF0002966, NPF0002968, NPF0002969, NPF0002970, NPF0002971, NPF0002972, NPF0002973, NPF0002974, NPF0002975, NPF0002977, NPF0002978, NPF0002979, NPF0002984, NPF0002988, NPF0002989, NPF0002993, NPF0002994, NPF0002995, NPF0002996, NPF0002998, NPF0003011, NPF0003012, NPF0003016, NPF0003020, NPF0003021, NPF0003022, NPF0003023, NPF0003024, NPF0003025, NPF0003026, NPF0003027, NPF0003028, NPF0003029, NPF0003031, NPF0003032, NPF0003033, NPF0003034, NPF0003035, NPF0003036, NPF0003038, NPF0003039, NPF0003040, NPF0003045, NPF0003049, NPF0003056 2) TH90QFA, UDI-Device Identifier (GTIN/UPN) 00763000582487, Serial Numbers: NPF0000658, NPF0000662, NPF0000673, NPF0000678 3) TH90PFA, UDI-Device Identifier (GTIN/UPN) 00763000433871, Serial Numbers: NPT0001313, NPT0051480, NPT0021804, NPT0051392, NPT0051144, NPT0001294, NPT0049798, NPT0053021, NPT0050685, NPT0001633, NPT0021799, NPT0051778, NPT0050614, NPT0001690 4) TH90GFA, UDI-Device Identifier (GTIN/UPN) 00763000187231, Serial Numbers: NPO0014927, NPO0011973, NPO0012969, NPO0041785, NPO0013871, NPO0041444, NPO0011977, NPO0012971, NPO0012000, NPO0013811, NPO0011986, NPO0012125, NPO0011971, NPO0008660, NPO0011724, NPO0011728, NPO0011734, NPO0012060, NPO0012531, NPO0013146, NPO0013205, NPO0013212, NPO0013226, NPO0014549, NPO0042926, NPO0043071, NPO0043184, NPO0043546, NPO0012112, NPO0012804, NPO0011909, NPO0013222 5) TH90G01, UDI-Device Identifier (GTIN/UPN) 00763000058005, Serial Numbers: NPO0042790, NPO0015230, NPO0053525 b) Model Number A51300, UDI-Device Identifier (GTIN/UPN) 00763000517182 c) Model Number A52300, UDI-Device Identifier (GTIN/UPN) 00763000517199
Root Cause
Software Design Change
Action Taken
Medtronic distributed a correction notice to impacted U.S. implanting physicians, who had implanted patients with the Model 97800 InterStim X system prior to the release of the software update or purchased the TH90Q kit (in addition to notifying, Medtronic Sales Representatives and Medtronic Patient & Technical Services) on 28-Feb-2022. Medtronic distributed a correction notice to impacted U.S. hospital accounts, who have purchased the TH90Q kit containing the affected HH90 handset prior to the software updated release, on 04-Mar-2022, notifying consignees of this issue and the software update availability. Medtronic will also notify those consignees with the TH90PFA and TH90GFA kits where the affected software was installed.