Medtronic Procedures Spur FDA Warning LetterJun 23, 2005 | AP
The Food and Drug Administration criticized Medtronic Inc.'s procedures for following up on complaints about an external defibrillator, including a failure to properly investigate a patient's death.
The FDA made public on Tuesday a warning letter to Fridley-based Medtronic regarding the LifePak 12 external defibrillator found in hospitals around the country.
The letter focused on damaged cable connectors in the devices, which are designed to deliver a powerful shock to patients experiencing sudden cardiac arrest. The damaged cables can cause the wrong amount of power to be delivered.
The problems highlighted in the document "may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems," the letter said.
Rob Clark, spokesman for Medtronic, said about 60,000 LifePak 12 devices are in circulation worldwide.
In May 2004, the company began an effort to replace faulty connector cables on 35,000 LifePak devices already in service, he said, adding that the effort is now about 95 percent complete.
The letter said FDA inspectors visited the plant in Redmond, Wash., where the LifePak 12 defibrillators are made, several times in February and March. In the letter, the FDA criticized the firm's manufacturing procedures.
Further, the FDA letter indicates Medtronic did not follow its own procedures when it failed to investigate a complaint involving the death of a patient.
Clark said an internal analysis of the defibrillator used to treat that patient revealed "no issues with the device, but we couldn't definitively rule it out."
He also said there was a second death in the past two years related to the issue with LifePak's connector cables. That death was not mentioned in the FDA's letter, dated June 9.
Clark noted that regulators were critical of the company's response to the patient's death, but not of the device itself.
The FDA told Medtronic it "should take prompt action to correct these deviations." Failure to do so, the regulators said, could result in regulatory or civil penalties.
Clark said Medtronic will meet with the FDA this week to resolve outstanding issues.