Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator

FDA device recall Z-0905-06 · posted 2006-05-25 · Terminated

Recall details

Recalling firm

Medtronic Inc, Neurological & Spinal Division

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.

Action taken

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

Status

Terminated

Product code

GZB

Quantity affected

101 devices affected

Distribution

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).

Date initiated

2005-11-22

Date posted

2006-05-25

Date terminated

2006-12-26

Location

Columbia Heights, MN