FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Medtronic’s DBS Pocket Adaptors Receive Hazard Alerts

July 26, 2016
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Medtronic Australasia, in consultation with Australia’s Therapeutic Good Administration, issued a hazard alert for two models of its Neuromodulation Deep Brain Stimulation system pocket adaptors in Australia.

The pocket adaptors (model numbers 64001 and 64002) are used with Activa PC and Activa RC neurostimulators.

Globally, 16 Medtronic Neuromodulation DBS system pocket adaptors have been returned due to high impedance, resulting in decreased current being conducted through the device. — Tamra Sami

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