Bloomberg News (6/27, Cortez) reports Medtronic’s “SynchroMed infusion pumps were linked to four flaws that have led to 14 patient deaths,” since 1996, and spurred the US Food and Drug Administration into placing its “most serious” level of recall on the implantable system. In a statement Wednesday, the “world’s largest heart device maker” announced that earlier this month, it sent notifications to customers “about the flaws that may interfere with the safe and reliable delivery of medications using the SynchroMed Implantable Infusion System.” Medtronic spokesperson Donna Marquard said that 11 of the 14 deaths were related to the “inadvertent injection of a drug into the patient’s subcutaneous tissue, rather than into the pump,” two deaths were attributed to “a blockage” and one, to an electrical shortage.
The Minneapolis Star Tribune (6/27, Walsh, 335K) adds that although the Fridley, Minneapolis-based manufacturer “told customers in early June about potential problems with the pump,” Medtronic decided to issue the “broader announcement Wednesday after” finding out that the FDA had “classified that correspondence as a Class I recall.” However, despite the problems, Marquard told the Tribune that the SynchroMed pump, which is “used to deliver drugs directly to the cerebral spinal fluid in patients,” has consistently shown “strong overall reliability, and Medtronic remains confident in its ability to deliver safe and effective therapy for those who need it.”