STORY FROM: MDL Mass Tort & Class Action Monitor
Medtronic Recalls SynchroMed Pain Pumps Due to Software Problem Leading to Possible Overdose
March 14, 2017
WASHINGTON, D.C. — Medtronic is recalling its SynchroMed Implantable Infusion Pain Pumps on the basis that a software problem may cause unintended delivery of drugs into the patient’s spine during a priming bolus procedure, according to a Food and Drug Administration alert.
The agency explained in the March 14 alert that during the procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery following procedure. That can result in a drug overdose or under dose which can lead to serious adverse health consequences such as ...