According to the Twin Cities Business Journal, the letter came after an inspection of Medtronic’s Mounds View Cardiac Rhythm Disease Management site and concerned: “Corrective and preventative action and field-action timeliness, review and documentation of field action recommendations, supplier qualification and controls, and medical-device reporting timeliness,” said the Business Journal. Medtronic has 15 days to respond to the warning letter.
Medtronic said it will respond to the letter within the mandated timeframe and stated that it is in the process of implementing revised processes in response to the letter, said the Business Journal. Medtronic also said that, according to the FDA’s letter, the agency wrote that the firm’s proposal “appear to be adequate to address the concerns raised in the letter and will be confirmed upon re-inspection,” quoted the Business Journal.
In a statement, Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic said, quoted the Business Journal, “Medtronic remains committed to providing the highest quality products to our customers and is working with FDA to resolve all remaining issues as quickly as possible.”
SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump
This is not the first warning letter Medtronic has received in recent months. In June we wrote that Medtronic received a warning letter regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump. In the letter, the FDA cited Medtronic for taking too long to recall the SynchroMed pumps.
The letter also said that an inspection conducted last year 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 are implantable devices used to deliver medicine to the spine. The devices have been recalled on several occasions.
According the FDA warning letter, 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 letter said.
potentially serious patient issues with MiniMed Paradigm Insulin Pumps
The pumps were recalled for this problem 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.”
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.
According to the letter, training records indicated that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.