Medtronic Infusion Pumps Recalled

Early this month, Medtronic Inc. notified customers about flaws in its Synchromed infusion pumps that may interfere with the safe and reliable delivery of medications. The flaws have led to 14 patient deaths. Now, the U.S. Food and Drug Administration (FDA) has issued a Class I recall on the pumps. 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.

The Minneapolis, Minn.-based medical device company’s Neuromodulation business issued a notice of corrective actions.

The first problem is to do with the priming bolus function, which is used to quickly move drug from the Synchromed pump reservoir to the catheter tip to initiate intrathecal drug delivery therapy while a patient remains under medical supervision. The company warned that any time the priming bolus is used with a Synchromed pump, the drug mixes with the sterile water or cerebrospinal fluid already in the catheter. This mixing results in the unintended delivery of drug prior to the end of the programmed bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. This can contribute to an increased risk of adverse events involving drug overdose or underdose following an initial system implant or revision.

Secondly, an electrical short could lead to the pump’s motor stalling, and a subsequently a loss of or reduction in therapy, which can result in the return of underlying symptoms and/or withdrawal symptoms. The Synchromed II pump is equipped with alarms designed to alert the patient in the event of a motor stall.

Medtronic has redesigned its sutureless connector catheter, which is part of the Snychromed system, to reduce the potential for occlusion, which is the blockage or cessation of drug flow due to misalignment at the point where the catheter connects to an implantable pump. As a result, the company has initiated a voluntary removal of unused products manufactured before the catheter design change.

Fourteen patients have died since 1996 while using the Synchromed system, Donna Marquard, a Medtronic spokeswoman, told Bloomberg. The most common complication was the inadvertent injection of a drug into the patient’s subcutaneous tissue, rather than into the pump, which led to 11 deaths. Two patients died from a blockage and another from an electrical short.