FDA-Device2016-06-15Class II
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.
Medtronic Neuromodulation
Hazard
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.
Sold states
Worldwide Distribution
Affected count
60,941
Manufactured in
7000 Central Ave, N/A, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1926-2016Don't want to check this manually?
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