Fourteen patient deaths, occurring between May 1996 and April 2013, have been associated with problems related to the SynchroMed implantable drug pump, according to the devices manufacturer, Medtronic, Inc. This has prompted the U.S. Food and Drug Administration to issue a Class 1 recall of the device based on “reasonable probability that use of these products will cause serious adverse health consequences or death.” The SynchroMed pump is used to treat patients who suffer from severe spasticity or intractable pain and for whom oral medication is ineffective. The implantable pump administers drugs directly into the cerebral spinal fluid. The first reason for the recall involves the “priming bolus function” which is used to transfer medication quickly from the pump reservoir to the catheter tip where the drug is delivered to the spinal fluid. Problems related to this function could lead to an under-dose or overdose of medication. Secondly, according to Medtronic, there is a potential for an electrical short circuit that could cause the pump to stall and lead to a loss of therapy, which, in turn, could result in the return of a patient’s underlying symptoms or drug withdrawal. Medtronic says the pump is equipped with alarms that will sound in the event of a motor stall and that it is working on design updates to deal with this issue. The third reason for the recall involves the pump’s Sutureless Connector (SC) catheter which has been redesigned to minimize the potential for blockage due to misalignment at the point where the catheter connects to the pump. Medtronic is recommending that customers discontinue use of all SC catheter models 8709SC, 8731SC, 8596SC and 8578 which were made before the design change and has initiated a voluntary removal of these unused catheters. In addition to these recalls, Medtronic has issued a safety update to the pump refill procedure, which reflects revised product labeling approved by the FDA. The safety update will help reduce the risk of healthcare professionals inadvertently injecting the medication into tissue around the pump instead of the pump reservoir, a mishap which has been associated with eleven patient deaths. Despite these issues, company spokeswoman, Donna Marquard says, the pump “continues to demonstrate strong overall reliability, and Medtronic remains confident in its ability to deliver safe and effective therapy for those who need it.”
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