Medical device manufacturer, Medtronic International Limited issued a medical device safety alert concerning the following products:
Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. If this happens, the damage would most likely occur at lead contact no.3 which could affect electrode contact no.3.
Medtronic further explained that depending on the extent of lead damage and the need to use electrode no.3, lead replacement may be required or optimal therapy may not be provided. Lead damage due to setscrew connector block twisting has been reported with 0.25% of the DBS leads distributed, however, this incidence is lower than the expected actual rate of occurrence since every event is not likely to have been reported and the actual number of uses of lead caps is unknown.
According to the manufacturer, there have been no reports of permanent patient impairment, life-threatening injury, or death as a result of this issue.
Medtronic is working on corrective actions to reduce the occurrence of setscrew connector block twisting which may result in lead damage. Physicians are reminded that every use of the lead cap provides an opportunity for lead damage to occur.
The local supplier confirmed that the affected products have been distributed in Hong Kong. They will send a letter to relevant physicians to inform them of the risk of lead damage and the actions that should be taken to mitigate occurrence.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 February 2013