Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its SynchroMed II Implantable Drug Infusion Pumps [Models 8637-20, 8637-40].
The manufacturer is voluntarily retrieving the affected products after investigating complaints related to permanent motor stall. The voluntary recall is being conducted due to the potential for the presence of a foreign particle inside the pump motor assembly which could interfere with motor gear rotation and lead to a permanent motor stall. The source of the foreign particle has been identified and eliminated.
According to the manufacturer, a permanent pump motor stall will result in cessation of drug infusion therapy which may result in return of underlying symptoms and/or withdrawal symptoms. For patients receiving intrathecal baclofen therapy, there exists the risk for Baclofen Withdrawal Syndrome, which can lead to a life-threatening condition.
As of 30 September 2019, the manufacturer has confirmed five reports of early permanent motor stall due to the presence of foreign particles from a manufacturing process. Of the five events, two were identified prior to implant; the other three occurred within 5 months of implant. In each case, the pump alarm functioned properly.
The manufacturer is not recommending prophylactic replacement of potentially affected products, due to the low observed occurrence of motor stall from the issue, the presence of pump alarms, and the risks associated with replacement surgery.
The users are advised to identify, locate, and segregate from use any affected unused product.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 October 2019