Medtronic SynchroMed Infusion Pump Problems Result in Consent Decree With FDA
Medtronic has entered into a consent decree with federal regulators for repeated errors and manufacturing problems involving the Synchromed II Implantable Infusion Pump Systems.
The consent decree was announced by the FDA on Monday, and requires the company to cease manufacturing, designing and distribution of new Medtronic Synchromed II infusion pumps, except in cases where a doctor determines it is medically necessary for a patient’s treatment.
The FDA accuses Medtronic and two of the company’s officers, S. Omar Ishrak and Thomas M. Tefft, of repeatedly failing to address manufacturing violations.
In addition to the halt of manufacturing, Medtronic must also retain a third-party expert to help develop plans to correct the violations. The consent decree will remain in effect until the FDA is satisfied that all of the Medtronic Synchromed problems have been addressed.
The SynchroMed Infusion Pump line has been plagued by issues over the last several of years. In February 2011, the FDA declared a Class I Medtronic 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 2011, 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.
In July 2012, the FDA sent a warning letter to Medtronic over the infusion pumps, ordering the company to put in place a plan to deal with reported failure problems. The FDA had received 567 complaints about motor corrosion in the SynchroMed II pump between then and October 2007. The corrosion caused gears to lose teeth, which lead to the motor seizing up.
The FDA press release states that the agency conducted five inspections between 2006 and 2013, which led to a total of three warning letters for major violations. Those violations involved failures to create processes for dealing with quality control problems. The company also failed to document design changes and make sure that the products it shipped out met design specifications.
“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” Jan Welch, acting director of the Office of Compliance in the FDA Center for Devices and Radiological Health, said in the press release. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”
1 comment
I had the Medtronic 11 pump placed in 2009 after about 3 or 4 years the alarm stopped going off & prior to that time I could barely hear it so I had no idea what it was & apparently my doctor was putting compound medications in hydromorphone & bubivicaine I had severe numbness & do not have brain function like I used to also my pump was tilted a strange way well I just had new pump put in on Friday & I had no Idea that the FDA & given them the consent decree was not told by my doctor well the new 1 I have feels like it is flipping around or inversion & having bowel issues & breathing difficulties only problem is there is no warnings or symptoms or signs to figure out if that is what is going on I have no way to find out but how can I trust if my doctor did not tell me about the FDA warning Medtronic how am I supposed to find out if I am having problems & when is it 2 late & past the point of no return I’m @ a loss & have no way to find out about this but I have serious pressure in stomach the pump has moved since Friday & I just don’t know who or where to find out Medtronic should have more info on their website of all symptoms associated with any problem that can arise & doctors should be BY LAW forced to tell ius about the FDA decree!! Plz help!!