August 22, 2012 — The FDA has issued a Warning Letter to Medtronic for failing to address safety issues with the SynchroMed II infusion pump.
The FDA believes those problems may have endangered patient safety .The agency has requested an independent outside review to confirm the company is handling complaints properly.
The FDA has received 567 complaints of corrosion. Although the problem was identified in October 2007, Medtronic never made a plan to address the problem or prevent future recurrences.
The SynchroMed II infusion pump is a device used to deliver painkillers. Unfortunately, corrosion in the motor can cause the failure of the device — including partial or complete corrosion of the gear teeth. These gears can seize and stall the motor, and fail to deliver painkillers to the patient. Patients may suffer severe withdrawal symptoms and increased pain when they are not receiving the painkillers. In some cases, the complications may be fatal.
Although Medtronic communicated the problem to healthcare professionals, the FDA concluded that this response was not adequate to address the problem.
The FDA has requested a meeting with Metronic to discuss the motor corrosion problem and Medtronic’s corrective actions. The FDA will also require a follow-up inspection to make sure Medtronic has set up procedures to address the corrosion problem — including receiving, reviewing, and evaluating complaints.
The FDA warning letter is not the first warning regarding the SynchroMed II. In February 2011, the FDA issued a Class I recall of the SynchroMed after finding that doctors were accidentally injecting painkillers directly into patients while they were attempting to refill the devices. At least 270 people were injured, and eight people died from painkiller overdoses.
In September 2011, the FDA initiated another Class I recall of the SynchroMed, after finding that the batteries could fail. A Class I recall is the FDA’s most urgent recall, reserved for defective devices that have a high risk of causing severe injury or death to patients. Medtronic has since received FDA approval for a new type of battery, and new SynchroMed II pumps continue to be sold.
Medtronic confirmed the corrosion issue with the SynchroMed, and said that the company is working to resolve the issue. Donna Marquard, company spokeswoman, said that “We remain confident in the SynchroMed II pump and its ability to deliver safe and effective therapy for people who need it.”