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Medtronic RestoreSensor, Model 37714 recallZ-1926-2016 · Medtronic Neuromodulation · initiated May 3, 2016

Class II Terminated All recalls posted in June 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1926-2016
Recall class
Class II
Status
Terminated
Initiated by the company
May 3, 2016
Posted by the FDA
Jun 7, 2016
Recalling firm
Medtronic Neuromodulation
Quantity
60,941
Product code
LGW
FDA submissions
P840001
Distribution
Worldwide Distribution

Product description

Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.

Code information (models, lots, serial numbers)

All lot/serial numbers are affected for both Model numbers 37714 and 97714.

Other devices under the same FDA submission

116 devices cleared under P840001 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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