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Terminated

Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy.

FDA Recall Z-0905-06 · Posted 2006-05-25

Recalling FirmMedtronic Inc, Neurological & Spinal Division
Recall StatusTerminated
Product CodeGZB
Date Initiated2005-11-22
Date Terminated2006-12-26
Product Quantity101 devices affected

Reason for Recall

A limited number of Model 37711 Restore Neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80% to 90% recharged. This anomaly does not affect patient safety. This anomoly can be corrected by reprogramming the Restore Neurostimulator using specific software.

Firm Action

A 'Customer Communication' letter was sent to Medtronic field personnel to hand-carry into the affected accounts; customer contact began on 11/22/2005. The letter explains the patients implanted with these devices likely will only be able to recharge their neurostimulator to about 80-90% of a full charge. This anomaly does not affect device safety or effectiveness but Medtronic will re-program them upon request for customer satisfaction. The letter will be followed by scheduled on-site visit to reset the internal memory parameter of the neurostimulator.

Root Cause

Other

Distribution Pattern

Nationwide (AZ, CA, FL, ID, IL, IN, KS, KY, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, and WI).

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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