RestoreSensor Implantable Neurostimulators 의 안전성 경고

Safety alert

2016-04-29

2016-04-29

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160429.html

Medical device safety alert: medtronic restoresensor implantable neurostimulators medical device manufacturer, medtronic, has issued a medical device safety alert concerning its restoresensor multi-program rechargeable neurostimulator and medtronic restoresensor surescan mri [product codes: 37714 and 97714] the manufacturer has confirmed four instances of loss of therapy during recharging of a restoresensor implantable neurostimulator, for a rate of 0.007% of devices distributed worldwide. by design, stimulation therapy turns off when battery voltage depletes below 3.575 volts. in the reported occurrences, a charging session was terminated prior to obtaining a recharge threshold voltage of 3.615, which triggered a rapid battery depletion state. as a result of the rapid battery discharge state, the implanted neurostimulators depleted to 1.925 volts (a state of overdischarge) in one to two days rather than the typical 30 days. according to the manufacturer, insufficient coupling (charging efficiency) between the recharger and the implanted neurostimulator during the recharge session was found to be a key factor in the reported events. once a device is in the over discharge state, therapy is interrupted with return of patient symptoms and can only be restored using the physician recharge mode of the recharger. as described in labeling, if three occurrences of overdischarge occur, the neurostimulator will trigger end of life, and must be replaced to restore therapy. affected users are advised to follow current recharge instructions, paying particular attention to charging efficiency and battery charge level indicators on the recharger. check the neurostimulator battery charge level once a day or more frequently as needed. keep the neurostimulator sufficiently charged to maintain therapy. it can be charged at any time; do not need to wait for a low battery message. during neurostimulator recharging, monitor the charging efficiency row and adjust the antenna to obtain as many solid black boxes as possible. if only two boxes are filled in (6 or more boxes are empty) adjust the antenna to improve the signal strength between the neurostimulator and recharger. during recharging, ensure the neurostimulator battery charge level is at least 25% before ending the charge session. however, a full battery charge is ideal. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 april 2016.