FDAnews Device Daily Bulletin

Medtronic Issues Warning on Deep Brain Stimulation Charger Malfunction

Oct. 21, 2016

Medtronic warned customers in early October of an issue with some of its Model 37751 rechargers for its deep-brain stimulation devices, saying they may become unresponsive and unable to fully recharge the neurostimulator until they are reset.

All rechargers manufactured since November 2014 are susceptible to the “error state,” which has been reported for 2 percent of all rechargers manufactured since that date and 0.2 percent sold before that date, the company said.

Medtronic has recommended that the charging device be plugged into the A/C power supply prior to recharging the neurostimulator and remain connected until the recharging session is complete. If the recharger is already unresponsive, the company suggested assisting patients with a reset of the recharger.

Medtronic said  it has not received notice of any life threatening injury or death associated with this problem. — Cynthia Jessup

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