Recall of Pump Device Hits Medtronic

Medtronic, the Fortune 500 world leader in medical technology with headquarters in Fridley, is responding to a Class I recall by the U.S. Food and Drug Administration of its SynchroMed implantable drug pump. 


According to the Star Tribune: 


Medtronic Inc. said Thursday that 14 patient deaths have been associated with problems involving its SynchroMed implantable drug pump. A day earlier, the device was the subject of recalls from the U.S. Food and Drug Administration. ...


The SynchroMed pump is used to deliver drugs directly to the cerebral spinal fluid in patients with intractable pain or who have severe spasticity and for whom oral medication is ineffective. Despite the problems with the pump, Medtronic spokeswoman Donna Marquard said the SynchroMed 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.”


in a separate article, the Star Tribune quoted a doctor on patient attitudes:


“Most of my patients, if I told them I wanted to take their pump out because of potential problems, they would say ‘Leave it in until you know for sure,’ ” said Dr. Diane Chappuis of the Courage Kenny Rehabilitation Institute in Minneapolis. “That is not to say that some patients don’t have a problem or two with their pump. But most of our patients don’t have a problem.” ...


Of the 14 deaths associated with the device, Medtronic said Thursday that one was from Minnesota.


Medtronic's own advice, in a press release posted at the company's website: 

Patients are encouraged to maintain regular follow-up appointments with their physicians; however, if they experience a change or return of symptoms or hear a device alarm, they should contact their physician immediately. ... The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 


Meanwhile, the Minneapolis/St. Paul Business Journal reported that Medtronic's general counsel is leaving July 15 for a job at Archer Daniels Midland (ADM).