U.K. healthcare regulators this month issued the latest in what has become a series of warnings on SynchroMed drug pumps manufactured by medtech titan Medtronic (NYSE:MDT), citing "serious risks" of potential over- or underdosing, electrical shorts and other issues.
The new alert comes on the heels of a March 2013 U.K. warning as well as a December 2012 FDA Class I recall for the SynchroMed line.
The U.K.’s Medicines & Healthcare Products Regulatory Agency noted 4 field safety notices in recent months concerning all models of the SynchroMed II and SynchroMed El products manufactured by Medtronic, citing "risk of drug under- or overdose due to various issues with these drug pumps."
Those concerns include a bolus priming issue that may lead to unintentional mixing of non-drug fluids, including cerebrospinal fluid and sterile water, the MHRA reported.
"Since drug mixing will occur any time the priming bolus is used with a SynchroMed pump, it is reasonable to expect that the resulting unintended drug delivery is a contributing factor to adverse events involving overdose and underdose," according to Medtronic field safety notice dated May 2013. "
The affected pumps may also be prone to electrical short circuits that could stall the device’s motor, preventing the flow of therapy and resulting in an underdose that "can lead to return of underlying symptoms and/or withdrawal syndrome, a life-threatening condition for patients receiving intrathecal baclofen therapy," according to the letter.
Medtronic recommended against prophylactic or preventative removal of the SynchroMed implants, but U.K. healthcare regulators asked that provider to take extra care with patients, increase monitoring and prime all new pumps prior to implant or connection to a catheter to reduce the risk of overdose.
The warnings were reiterated by the Hong Kong Dept. of Health, which noted that the devices, most of which are fading from use, may fail at any time.
"All SynchroMed II and SynchroMed EL pumps can potentially be affected by this issue at any time throughout the life of the device, regardless of drugs used in the pump," according to China healthcare regulators. "The SynchroMed EL has been discontinued and based on Medtronic data, at least 90% of the remaining actively implanted SynchroMed EL pumps are near expected end of service."
The SynchroMed line has been the subject of a few recalls in recent years. In July 2011 Medtronic warned that some of its SynchroMed II pumps may have defective batteries that could result in sudden device failure. By the time the warning was made public more than 50 confirmed battery defect failures had occurred. The battery issue spurred an FDA Class I recall, a label reserved for medical device recalls considered of the highest potential risk to patients.
The devices were subject to yet another Class I FDA recall when in December 2012 Medtronic said it had received reports of higher-than-expected rates of failure when the implantable SynchroMed II pumps were used with "unapproved drugs."
Earlier this year a 9th Circuit Court of Appeals ruled that a case against the medical device giant and its implantable pain pumps may proceed. The 9th Circuit’s 3-judge panel in January decided that plaintiff Richard Stengel, who had the pump implanted into his abdomen in 2000, could proceed with his negligence claims against Medtronic.