Medtronic SynchroMed Pumps May Be Affected by Multiple Issues

Four safety warnings were issued this week for Medtronic, Inc.’s SynchroMed Implantable Infusion System Pumps, involving problems with the priming pump, a risk of internal electrical shorts and two updates available to address issues with the pump systems that resulted in a January 2011 recall.

According to an “Urgent Medical Device Correction” letter (PDF) issued by Medtronic this month, issues with the SynchroMed Implantable Infusion Pump priming bolus may affect the functioning of the pump.

The bolus priming pump sends the medication from the reservoir to the catheter tip. That action has been classified as a recall to address the priming issue, which may send unintended doses of prescription drugs to the patient, contributing to an overdose or an under dose of medication.

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The Medtronic SynchroMed infusion pump helps to treat chronic pain, muscle tightness or severe cerebral spasticity in patients who use the device. The recall notification does not include external insulin pumps for diabetes.

A second warning letter (PDF) issued by Medtronic involves issues of internal electrical shorts with the SynchroMed Implantable Infusion pumps. Electrical shorts occur when ions from the drug solution and humidity interact and affect the drug pathway tubing inside the pump. This can affect the path in which the electrical current flows.

Interrupting this path may cause pump motors to stall, reduce and even stop drug delivery to the patient, resulting in severe side effects and possibly death. Since 2004, nearly 400 shorts have occurred to infusion pumps, only one percent of the more than 180,000 pump implants worldwide.

An additional safety update letter (PDF) has been issued following a January 2011 recall over problems with pocket fills in the pump, which may cause inadvertent injection of some or all the medication to a patients tissue. The update offers information to the “Critical Actions in the Pump Refill Procedure” section and a reference card (PDF) to supplement the refill kit labeling. The card offers a way to assess the needle position throughout a pump refill procedure.

All the letters have been categorized by the FDA as class 1 recalls, which is the most serious type of medical device recall. It is issued when there may be significant potential for a product to cause severe side effects and even death.

Medtronic advises customers to maintain any regularly scheduled followup appointments with healthcare providers. In the event of a change or return in symptoms, patients should contact their doctor immediately.


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