Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
- Company
- Medtronic Xomed, Inc.
- Recall Initiated
- September 27, 2010
- Posted
- September 10, 2012
- Terminated
- November 26, 2013
- Recall Number
- Z-2343-2012
- Quantity
- 53
- Firm Location
- Jacksonville, FL
Reason for Recall
In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
Distribution
Worldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom.
Lot / Code Info
8253410 (Neuro). All Serial Numbers.
Root Cause
Device Design
Action Taken
The firm, Medtronic USA, Inc., sent an "URGENT Product Recall Notification" letter dated September 27, 2010, to its U.S. and International customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify their receipt of this notice and complete and sign the Product Replacement checklist form indicating that their sales representative has completed the replacement of their devices and fax to 1-651-367-8055. U.S. Customer Units - replacement kits with their contents will be provided to each Area Sales Manager (ASM) for each customer along with documentation of serial number units to be replaced. Each ASM will be responsible for delivering a replacement unit(s) and picking up and returning each of their customer's units using the pre-labeled replacement kit boxes. International Customer Units- International units, depending on the geography will either be replaced or repaired and returned. If replacement is planned, the International Business Manager (IBM) will receive replacement kits as described for the U.S. In those geographies where devices will be repaired and returned, kits with the following contents will be sent to IBM's along with documentation of serial number units to be repaired. Foreign distribution: In the larger territories (i.e. Australia, Japan, Canada, EMEA-Europe, Middle East, Africa), repairs/rework were handled at the Medtronic facilities in those geographic areas. In the smaller geographic areas (Singapore, Thailand, Hong Kong, Korea, Latin America ), where there were limited sales, devices were returned to the U.S. In all cases (large and small geographic areas), devices were returned via a Medtronic entity (sales office or distribution center). If you have any questions regarding the subject Actron or the content of this letter, contact the Distinguished Regulatory Affairs Advisor at 904-279-7532.