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FDA Warning Letter Cites Medtronic’s Delay In Issueing SynchroMed II Pump Recall

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A Food & Drug Administration (FDA) warning letter says that Medtronic Inc. waited too long to issue a recall of its  SynchroMed II  Drug Pumps, and did not respond properly to reports of problems with MiniMed Paradigm Insulin Pump.

The FDA warning letter stemmed from an inspection of Medtronic’s Puerto Rican facility where the pumps are made that occurred from  November 12, 2008 through December 15, 2008. 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.

SynchroMed pumps were recalled in May 2008, after Medtronic received two reports of SynchroMed pumps being removed from patients because of a lack of propellant.  “FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner,” the  warning letter, dated June 1, states. “It took almost two years from when the missing propellant was initially identified to conduct a recall.”

According the FDA warning letter, some SynchroMed pumps were released for distribution and implanted in patients even though they were not filled with the  needed propellant. The problem was not discovered during the manufacturing process even though the pumps went through a propellant weight check, the letter said.

The FDA letter also criticized Medtronic for failing 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.

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