Medtronic RestoreSensor Implantable Neurostimulators Recalled for Battery Depletion
Medtronic is recalling RestoreSensor implantable neurostimulators because insufficient coupling during recharging can cause rapid battery depletion and loss of therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of pain therapy) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Neuromodulation is recalling 60,941 units of RestoreSensor (Model 37714) and RestoreSensor SureScan (Model 97714) implantable neurostimulators. These devices are used to treat chronic, intractable pain of the trunk and/or limbs. The recall covers all lot and serial numbers for both models and involves worldwide distribution.
The recall is due to a risk of loss of therapy during the recharging process. Reports indicate that a charging session may terminate before reaching the required recharge threshold voltage of 3.615 volts. This triggers a rapid battery depletion state, causing the device to drop to 1.925 volts in one to two days instead of the typical 30 days. Insufficient coupling between the recharger and the device during the recharge session was identified as the key factor.
Patients using these devices should contact their healthcare provider or Medtronic for instructions on how to proceed. The source text does not specify a particular consumer action beyond the general context of a medical device recall.
The recalled product
- 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.
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 60,941
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot/serial numbers are affected for both Model numbers 37714 and 97714.
Distribution
Distribution scope not specified by the agency.
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