Recall Z-1926-2016— Medtronic Neuromodulation
Class II · Terminated
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2016-05-03, terminated 2017-08-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-03
- Terminated
- 2017-08-04
- Firm location
- Minneapolis, MN, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.