Medtronic Inc. received a warning letter on June 1, 2009 from the FDA regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump. The FDA citesMedtronic for taking too long to recall the SynchroMed Pumps. The letter also said that a 2008 inspection at the Puerto Rican plant where both pumps were made found that Medtronic failed to establish and maintain quality controls in manufacturing.
SynchroMed II pumps,implantable devices used to deliver medicine to the spine, have been recalled on several occasions including in May 2008. The Pumps were recalled in 2008 because some SynchroMed pumps were released for distribution and implanted in patients even though they were not filled with a needed propellant. The problem was not discovered during the manufacturing process even though the pumps went through a propellant weight check, the FDA letter said. The letter went on to say, “FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner. It took almost two years from when the missing propellant was initially identified to conduct a recall.”
The FDA letter also noted that Medtronic failed to notify the agency within 30 days of at least two reports of potentially serious patient issues with MiniMed Paradigm Insulin Pumps, and for failing to have a person qualified to make a medical judgment determine if reported problems had anything to do with a patient’s death or serious injury. Training records showed that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.
The company has 15 working days from the date it received the warning letter to respond to the FDA. The FDA letter warned Medtronic that failure to promptly correct violations could result in regulatory action being initiated without further notice.