Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).
This recall is currently active, issued September 11, 2023. It was issued by Abbott Medical.
- Company
- Abbott Medical
- Recall Initiated
- July 18, 2023
- Posted
- September 11, 2023
- Recall Number
- Z-2508-2023
- Quantity
- 387 devices (US only)
- Firm Location
- Plano, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.
Lot / Code Info
Model Number: 3672 UDI-DI Codes: 05415067046406 Serial Numbers: US CBW328.1 CCA167.1 CCA177.1 CCU613.1 CCV760.1 CCX700.1 CCY890.1 CDR307.1 CDW220.1 CEC548.1 CEC719.1 CEE095.1 CEH111.1 CEH156.1 CEH200.1 CEH272.1 CEH293.1 CEH334.1 CEH964.1 CEH975.1 CEH993.1 CEK127.1 CEK258.1 CEK265.1 CEK271.1 CEK310.1 CEK432.1 CEM232.1 CEM340.1 CEM349.1 CEM375.1 CEM383.1 CEM396.1 CEN429.1 CEN444.1 CEP494.1 CEP497.1 CEP537.1 CEP540.1 CEP541.1 CEP553.1 CEP554.1 CEP562.1 CEP585.1 CEP645.1 CEP658.1 CEP663.1 CEP671.1 CEP685.1 CEP725.1 CEP730.1 CEP838.1 CEP847.1 CEP867.1 CER393.1 CER395.1 CER462.1 CER482.1 CER509.1 CER576.1 CET134.1 CET147.1 CET298.1 CET336.1 CET343.1 CET649.1 CEY608.1 CEY648.1 CFL299.1 CFL403.1 CFL540.1 CFL582.1 CFP963.1 CFP987.1 CFP991.1 CFR079.1 CFR100.1 CFR121.1 CFR392.1 CFR446.1 CFR478.1 CFR585.1 CFU079.1 CFU082.1 CFU091.1 CFU097.1 CFU098.1 CFU099.1 CFU121.1 CFU126.1 CFU132.1 CFU145.1 CFU333.1 CFU401.1 CFU426.1 CFU441.1 CFU460.1 CFU467.1 CFU472.1 CFU483.1 CFU526.1 CFU547.1 CFU569.1 CFU646.1 CFU687.1 CFV457.1 CFV588.1 CFV718.1 CFX211.1 CGA013.1 CGA029.1 CGA065.1 CGA097.1 CGA145.1 CGA331.1 CGA365.1 CGA406.1 CGA426.1 CGA451.1 CGA491.1 CGA500.1 CGA515.1 CGA581.1 CGC898.1 CGC908.1 CGC916.1 CGC921.1 CGC926.1 CGC955.1 CGC957.1 CGD063.1 CGD070.1 CGD076.1 CGD085.1 CGD101.1 CGD111.1 CGD119.1 CGD123.1 CGD192.1 CGD193.1 CGD220.1 CGD231.1 CGD240.1 CGD248.1 CGD251.1 CGD277.1 CGD278.1 CGD283.1 CGD308.1 CGD342.1 CGD343.1 CGD362.1 CGD694.1 CGD719.1 CGD739.1 CGD777.1 CGD790.1 CGD832.1 CGD892.1 CGG890.1 CGH131.1 CGH175.1 CGH183.1 CGH199.1 CGH245.1 CGH346.1 CGH413.1 CGL108.1 CGL207.1 CGL321.1 CGL863.1 CGL866.1 CGL889.1 CGP051.1 CGP078.1 CGP326.1 CGP615.1 CGS914.1 CGW231.1 CHB011.1 CHE598.1 CHE845.1 CHF161.1 CHF178.1 CHH717.1 CHH744.1 CHH773.1 CHJ032.1 CHK331.1 CHK354.1 CHK434.1 CHK648.1 CHM211.1 CHM389.1 CHM509.1 CHP603.1 CHP605.1 CHP621.1 CHR155.1 CHR240.1 CHT217.1 CHT238.1 CHT240.1 CHT241.1 CHT243.1 CHT245.1 CHT272.1 CHT356.1 CHT361.1 CHT373.1 CHT469.1 CHT478.1 CHT539.1 CHT553.1 CHT561.1 CHT589.1 CHT609.1 CHT624.1 CHT758.1 CHT815.1 CHT834.1 CHV674.1 CHV680.1 CHV710.1 CHV713.1 CHV794.1 CHV901.1 CHV989.1 CHW217.1 CHW262.1 CHW263.1 CHW306.1 CHW350.1 CHW362.1 CHW526.1 CHW560.1 CHW590.1 CHW591.1 CHW640.1 CHZ471.1 CHZ563.1 CHZ576.1 CJA246.1 CJG129.1 CJG177.1 CJM932.1 CJM940.1 CJN773.1 CJN780.1 CJN879.1 CJN987.1 CJP047.1 CJW418.1 CJW475.1 CJW534.1 CJW548.1 CJW586.1 CJX925.1 CJX962.1 CJX982.1 CJX986.1 CJY012.1 CJY075.1 CJY111.1 CJY226.1 CJY238.1 CJY304.1 CJY323.1 CJY360.1 CJY409.1 CJZ061.1 CJZ103.1 CJZ135.1 CJZ157.1 CJZ224.1 CJZ241.1 CJZ253.1 CJZ256.1 CJZ283.1 CJZ293.1 CJZ300.1 CJZ330.1 CJZ420.1 CJZ444.1 CJZ450.1 CKB402.1 CKB428.1 CKB439.1 CKB447.1 CKB487.1 CKB507.1 CKB608.1 CKB624.1 CKB654.1 CKB696.1 CKB725.1 CKB767.1 CKB887.1 CKD072.1 CKF569.1 CKF587.1 CKG394.1 CKG550.1 CKG586.1 CKG607.1 CKG915.1 CKG954.1 CKG956.1 CKG962.1 CKH467.1 CKH606.1 CKH692.1 CKH719.1 CKH736.1 CKH765.1 CKH774.1 CKH786.1 CKH815.1 CKH859.1 CKH923.1 CKL195.1 CKL217.1 CKL236.1 CKL295.1 CKL345.1 CKL464.1 CKL487.1 CKP251.1 CKP255.1 CKP277.1 CKP291.1 CKP393.1 CKP435.1 CKP483.1 CKP495.1 CKP563.1 CKP656.1 CKP678.1 CKP682.1 CKP717.1 CKP733.1 CKP803.1 CKP939.1 CKS483.1 CKS519.1 CKS531.1 CKS552.1 CKS588.1 CKS590.1 CKS616.1 CKS641.1 CKS662.1 CKS673.1 CKS684.1 CKS692.1 CKS698.1 CKS706.1 CKS827.1 CKS856.1 CKS869.1 CKS954.1 CKS986.1 CKS992.1 CKS994.1 CKS997.1 CKT159.1 CKY723.1 CKY781.1 CLC604.1 CLD150.1 CLD293.1 CLF739.1 CLF855.1 CLF880.1 CLF888.1 CLF901.1 CLG005.1 CLG094.1 CLG124.1 CLG391.1 CLG393.1 CLG395.1 CLG396.1 CLG423.1 CLG457.1 CLG534.1 CLK164.1
Root Cause
Under Investigation by firm
Action Taken
On 07/20/2023, the firm will send an "URGENT MEDICAL DEVICE CORRECTION" Letter via mail with delivery tracking to customers informing them, Abbott has received complaints from patients who are unable to exit MRI mode, as their Patient Controller has lost the ability to connect or communicate with their IPG while in MRI mode. Situations where this has occurred include where the user deleted the Bluetooth pairing, lost or disabled their Patient Controller, or upgraded the iOS! software on their Patient Controller while in MRI mode. Next Steps for Customers: Per Abbott's Instructions for Use, patients are advised to contact their physician before having an MRI to discuss all critical information regarding MRI scans and MRI mode. In alignment with the Clinician Programmer and Patient Controller Instructions for Use, Abbott recommends physicians do the following: " For the Patient Controller, advise the patient not to delete the paired Bluetooth connection between their IPG and the Patient Controller and not to alter, damage or lose their Patient Controller while the IPG is in MRI mode. " For the Patient Controller prior to entering MRI mode, ensure patients have upgraded their Patient Controller to the latest "Patient Controller NR - US" application from the Apple! App Store!. This version of the application provides instructions for the user not to delete the IPG pairing while the system is in MRI mode. " For the Clinician Programmer, maintain the paired Bluetooth connection between the IPG and the Clinician Programmer by avoiding deleting the pairing and disabling automatic iOS! software upgrades from the iOS! settings. " For questions about this issue or to report patients who are unable to exit MRI mode, please contact your local Abbott representative or Abbott Technical Support at 1-800-727-7846 (option 3) for assistance.