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Recall Observatory FDA recall evidence

Device 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.

Z-1926-2016

May 03, 2016

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 74059
Status
Terminated
Classification
Class II
Quantity
60,941
Official record key
device-enforcement:Z-1926-2016

Official wording

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.

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

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.