—#150430

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.

FDA product code: MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P960009S051
Affected lot / code info: serial numbers beginning with NKA4 or NKU4

Why it was recalled

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.

Root cause (FDA determination)

Software change control

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave, Minneapolis, Minnesota 55421-1241

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide including DC OUS: Canada and others.

Timeline

Recall initiated: 2016-10-03
Terminated: 2022-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150430. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.