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U.S. Department of Health and Human Services

Class 2 Device Recall Recharger

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  Class 2 Device Recall Recharger see related information
Date Initiated by Firm October 03, 2016
Create Date December 03, 2016
Recall Status1 Terminated 3 on May 04, 2022
Recall Number Z-0700-2017
Recall Event ID 75458
PMA Number P960009S051 
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Product Model 37751 Recharger

Product Usage:
The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger, an AC power supply and power cord (Model 37761) and an antenna.
Code Information serial numbers beginning with NKA4 or NKU4
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave
Minneapolis MN 55421-1241
For Additional Information Contact Medtronic Technical Services
800-707-0933
Manufacturer Reason
for Recall		 Medtronic has identified an increased number of complaints from customers involving reports of Rechargers (Medtronic Model 37751 Recharger, which is included in Models 37754 and 97754 Charging Systems,Spinal Cord Stimulation)that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 seconds. Medtronic has determined all Rechargers manufactured starting in November 2014 (indicated by serial numbers beginning with NKA4 or NKU4) are more susceptible to this error state.
FDA Determined
Cause 2		 Software change control
Action Consignees were sent a series of documents which included an introductory Medtronic and "Urgent Medical Device Correction" letters dated September 2016. The urgent letters included one for Deep Brain Stimulation (DBS) and one for Spinal Cord Stimulation(SCS) . Each letter was addressed to Healthcare Professional. Only physicians associated with both SCS and DBS therapy received the cover letter. The letters provided information on "Background, Issues Mitigation, Recommendation, Additional Information and Patient Notification (DBS). Requested consignees to complete and return the Physician /HCP Reply Form. For questions contact Medtronic Technical Services at 1-800-707-0933 weekdays 7 am to 6pm, CT.
Quantity in Commerce 42,887
Distribution Worldwide Distribution - US Nationwide including DC OUS: Canada and others.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MHY and Original Applicant = MEDTRONIC Inc.
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