Medtronic Admits 14 Deaths Linked to SynchroMed Drug Infusion PumpJun 27, 2013
Medtronic admitted this week that 14 deaths can be attributed to use of its SynchroMed drug infusion system.
The Wall Street Journal reports that the medical device maker said this week that most of the deaths linked to the SynchroMed device were caused either by overdoses or deprivation of medication that caused fatal withdrawal symptoms. In some cases, the device’s own faults caused deaths to occur.
Medtronic says that the SynchroMed devices needn’t be removed, but the U.S. Food and Drug Administration (FDA) issued its most serious warning on the implanted device, deeming Class I recalls on four defects the agency found with the devices, according to the Wall Street Journal.
The FDA reserves Class I recall warnings for medical devices it believes will cause serious injuries or death to patients who use them. Earlier this month, Medtronic identified two new defects with implanted SynchroMed devices and notified the FDA. These defects are in addition to a pair of other problems that Medtronic itself had identified. A Medtronic spokesperson told the Wall Street Journal that patients who notice a change in or return of symptoms while using the SynchroMed should notify their physicians immediately. Additionally, if they hear an alarm, that likely means that the device is not working properly and could cause adverse reactions.
Medtronic reports that 11 of the 14 deaths linked to the SynchroMed have been reported since 1996 and were caused by “patients being inadvertently injected with drugs with a medication-refill procedure,” according to the Wall Street Journal.
More recent deaths linked to the devices appear to be attributed to device failures, based on the Wall Street Journal report. Two deaths, reported since 2007, were linked to a blockage of the drug flow from the device to the patient. A death in March of this year was caused by an electrical short circuit.
In reaction to the FDA Class I recall designations as well as the admission that 14 deaths could be linked to these SynchroMed drug infusion pumps, Medtronic has issued several warnings to physicians who prescribe the use of these devices. In one warning, Medtronic tells doctors to be aware of the pump-priming mechanism. This part controls the dosing of the drug being infused through SynchroMed. In another warning, physicians should alert patients using SynchroMed that hearing an audible warning should prompt an emergency call for help: It could lead to a drug not being delivered, according to the Wall Street Journal report.