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Recall Observatory FDA recall evidence

Device 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.

Z-0700-2017

October 03, 2016

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 75458
Status
Terminated
Classification
Class II
Quantity
42,887
Official record key
device-enforcement:Z-0700-2017

Official wording

Reason: 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.

Code information: serial numbers beginning with NKA4 or NKU4

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.