Medtronic Manufacturing Violations Puts Patients at Risk: FDA Letter

Medtronic’s failure to adequately address reported problems with its SyhcnroMed II infusion pump may have placed patients at risk of serious injury, federal regulators say. 

The FDA sent a warning letter to Medtronic last month, calling for the company to put in place more effective corrective actions to deal with the infusion pumps’ problems. The company faces seizure of products, injunction and fines if it does not promptly deal with the violations, the FDA warned.

According to the letter, the FDA has received at least 567 complaints about motor corrosion in the SynchroMed II pump since October 2007. The corrosion causes gears to lose teeth, which lead to the motor seizing up. These resulted in the device’s motor stalling, preventing it from delivering drugs to the patient.

Medtronic tried to deal with the problem by sending a letter to healthcare professionals and trying to decrease the risk of corrosion, but those efforts have not been enough, the FDA’s warning letter states. Complaints continue to come in and the failed infusion pumps have caused, and will cause, patient injuries, according to the FDA.

FDA officials are asking to meet with Medtronic about the issue on September 7.

Medtronic Failed to Make Records of Complaints

The letter came after FDA inspectors investigated the Medtronic Neuromodulation facility in Minneapolis, Minnesota from March 14 through May 9. The facility manufactures implantable drug infusion systems, deep brain stimulation systems, and other nerve and neurological implants. The FDA said that all of the devices could be at risk due to the company’s failure to put in place a system that takes effective corrective actions.

One of the problems identified was the company’s response to complaints from doctors and other health care providers. The inspectors found that the company failed to make written documentation of some complaints it received by phone. However, the FDA letter said that Medtronic had proposed an adequate solution to address the problem. A future inspection will be needed to see if that solution actually works.

The SynchroMed Infusion Pump line has been plagued by problems over the last couple of years. In February 2011, the FDA declared a Class I Synchromed pump recall following reports that doctors were accidentally injecting drugs directly into patients’ subcutaneous tissues while attempting to refill the devices. These “pocket fills” resulted in at least eight deaths and 270 injuries requiring medical intervention.

In September of last year, a Synchromed II battery recall was announced after the company received reports of batteries becoming covered with a thin film and failing. The FDA classified that as a Class I recall as well. Class I medical device recall classifications mean that the FDA believes the device has a reasonable likelihood of causing severe injury or death.

The letter, dated July 17 but not released until this week, gave the company 15 days to respond to the FDA’s allegations and propose plans to address those problems.

In 2009, the FDA sent a similar warning letter to Medtronic over a lack of quality control at its Puerto Rico plant. Following an investigation, the FDA indicated that the company had problems with reporting and investigating device malfunctions that may be “symptomatic of serious problems” in Medtronic’s manufacturing and quality assurance procedures.