August 22, 2012 — The FDA has issued a Warning Letter to Medtronic for potentially endangering patient safety by failing to address safety concerns and complaints about the SynchroMed II infusion pump.

Medtronic has known about a corrosion defect with the pump since October 2007, and 567 complaints of corrosion have been sent to the FDA. Despite the large number of complaints, the FDA is concerned that Medtronic lacked an adequate plan to address these complaints, correct the problem, or prevent future recurrences.

Medtronic’s SynchroMed II infusion pump is a type of “pain pump” that automatically delivers painkillers. Unfortunately, parts inside the motor can corrode, causing the “teeth” on the gears of the motor to seize and stall the motor. When this occurs, the SynchroMed will not deliver any painkillers to the patient. The lack of painkillers can cause the patient to suffer from increased pain. They may also suffer severe withdrawal symptoms, which can be fatal in some cases.

When Medtronic discovered the problem in 2007, they sent a notification to physicians about the problem. In a new warning letter, the FDA has called this response inadequate.

The FDA has requested a meeting with Medtronic executives to discuss the company’s response to the problem, or lack thereof. Once Medtronic has made a plan for how they will address future complaints, the FDA will schedule a follow-up inspection to ensure that Medtronic has an adequate system in place to receive, review, and evaluate complaints.

This is not the first time the FDA has taken action regarding the SynchroMed II. In February 2011, the FDA issued a Class I recall after receiving reports of patient deaths that occurred when physicians accidentally injected people with painkillers while trying to refill the SynchroMed. The FDA identified eight deaths and 270 injuries.

Another Class I recall was initiated in September 2011. This recall was initiated after finding that the batteries in the device could fail prematurely. The FDA reserves Class I recalls for defects that are at immediate risk of causing a life-threatening injury or death. Medtronic developed a new, safer type of battery, and new devices are back on the market.

Medtronic officials said that they are aware of the corrosion issue, and they are working to resolve problems identified by the FDA. 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.”


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