Device maker, Medtronic Inc., announced that 14 deaths have been associated with its SynchroMed Infusion System.
The implantable SynchroMed Infusion System treats chronic pain and spasticity, according to the Wall Street Journal. Most of the deaths took place when patients were deprived of medication and went into withdrawal or following an overdose, Donna Marquard, a Medtronic spokeswoman told the Journal.
Medtronic said it is not recommending patients have the implantable devices removed at this time, but does suggest that patients speak to their doctors immediately should they notice a change, if they hear a device alarm, or if they experience a return of symptoms, the Journal wrote. The device alarm is in place to alert patients that the SynchroMed’s motor has stalled.
Medtronic identified four issues with the SynchroMed device, communicating these issues to physicians early this month. Two issues were previously reported and the U.S. Food and Drug Administration has classified all four as Class 1 recalls, according to the Journal. A Class I recall designation is the agency’s most serious and involves situations in which there exists a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.
Ms. Marquard told the Journal that 11 deaths took place from 1996 and April 2013 and were associated with patients being inadvertently injected with drugs with a medication-refill procedure, according to the Journal. Two of the deaths were attributed to a blockage of drug flow from the device; those deaths took place from 2007 and February 2013. One death, which occurred in March 2012, was attributed to an electrical shorting of the SynchroMed device.
According to Medtronic, more than 200,000 SynchroMed devices have been implanted worldwide, said the Journal.
Notifications include recommendations for health care professionals over the device’s pump priming mechanism. This mechanism can contribute to increased improper dosing risks. Medtronic continues to investigate the matter and indicated that it will make a determination concerning appropriate product updates, according to the Journal.
The second notification discussed the possible risk of an electrical short within the SynchroMed pump, which has an alarm to alert patients. Should the alarm sound, patients are urged to contact their doctor. Medtronic does not recommend removal of the device unless signs of malfunction occur; the device maker estimates the failure rate to be less than 1 percent seven years following implantation, according to the Journal.
Medtronic indicated that it is implementing removal of some unused sutureless connector catheters it redesigned to reduce blockages and is also distributing revised instructions for its SynchroMed Implantable Infusion System pump-refill procedure, according to the Journal.
As we’ve written, although motor stalls can take place whether approved or unapproved drugs are used with the devices, the stalls occur at a much higher rates when unapproved drugs are used. The FDA and Medtronic advised patients and health care professionals to provide constant monitoring of a patient using a SynchroMed pump to deliver their drugs.
Infusion pumps are often used in patients who require constant or round-the-clock medical care or who must receive a certain drug on a consistent basis or over a longer period of time. The risk of a SynchroMed motor stalling is still present even if an approved drug is used and patients should always be monitored if they’re using a SynchroMed or any type of drug infusion pump.