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U.S. Department of Health and Human Services

Class 2 Device Recall RestoreSensor and RestoreSensor SureScan

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  Class 2 Device Recall RestoreSensor and RestoreSensor SureScan see related information
Date Initiated by Firm May 03, 2016
Date Posted June 07, 2016
Recall Status1 Terminated 3 on August 04, 2017
Recall Number Z-1926-2016
Recall Event ID 74059
PMA Number P840001 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product 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 All lot/serial numbers are affected for both Model numbers 37714 and 97714.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave
Minneapolis MN 55421-1241
For Additional Information Contact Medtronic Neuromodulation Technical Serv
800-707-0933
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 60,941
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LGW and Original Applicant = MEDTRONIC NEUROMODULATION
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