Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Use

FDA device recall Z-1926-2016 · posted 2016-06-07 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615, which triggered rapid battery depletion state. As a result, the device depleted to 1.925 volts in one to two days rather than the typical 30 days. Insufficient coupling between recharger and device during recharge session was found to be key factor.

Action taken

Consignees were sent on 5/3/2016 a Medtronic "Urgent Medical Device Safety notification" letter dated May 2016. The letter was addressed to "Healthcare Professional". The letter described the problem and the product involved in the recall. The letter listed the recommendation to patients to follow current recharge instructions, paying particular attention to Charging Efficiency and Battery Charge Level indicators on the recharger. Consignees were also requested to complete and return the "Physician Reply Form:. For questions contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekdays 7 am - 6 pm CST.

Root cause

Under Investigation by firm

Status

Terminated

Product code

LGW

Quantity affected

60,941

Distribution

Worldwide Distribution

Date initiated

2016-05-03

Date posted

2016-06-07

Date terminated

2017-08-04

Location

Minneapolis, MN