In a letter made public June 21, 2005, the U.S. Food and Drug Administration warned Medtronic Emergency Response System, a unit of Medtronic, Inc., that its failure to correct manufacturing problems or investigate complaints regarding its LifePak 12 external defibrillators may force the company to face civil and legal penalties. External defibrillators deliver powerful electrical shocks to the chest in order to restore the heart’s natural rhythm.

The letter highlighted a problem with the LifePak 12 involving broken or bent pins in therapy cables connected to the device, which is used to treat patients experiencing sudden cardiac arrest. The damaged cables in some of the LifePak 12 defibrillators caused them to deliver inappropriate energy levels while in use, resulting in numerous complaints.

The FDA inspected Medtronic, Inc.’s plant in Redmond, WA, in February and March, 2005, on several occasions after Medtronic, Inc. recalled about 87,000 units of another implantable defibrillator after the discovery of battery failures. At that time Medtronic, Inc. promised to remedy manufacturing problems despite citing an “internal analysis” of the LifePak 12, which they claimed revealed no issues with the device.

The recently published letter by the FDA states that Medtronic, Inc. has failed to adequately correct manufacturing problems related to its defibrillators. The company also violated its own internal safety procedures when it did not open an investigation on a defibrillator complaint involving a patient death.

The letter stated, “There have been continued complaints of broken pins in the therapy cables used with the new redacted connector” intended to remedy the flaw. The FDA pointed to inadequate inspection procedures as one possible source of the problem.

Earlier this year, Medtronic, Inc. recalled 1,924 LifePak 500 external defibrillators due to 54 incident reports about a malfunction in the model that caused the units to display a “connect electrodes” message even when the device was properly connected. This flaw prevented patients from being properly defibrillated. The Redmond facility in which they were manufactured was previously owned by Physio-Control, a Washington company that first commercialized the defibrillator. Manufacturing in the facility was shut down for an entire year in 1992 after an FDA inspection raised questions about its quality-control procedures.

Medtronic, Inc.’s cardiac-rhythm management business, which also includes pacemakers, accounted for approximately 46% of the company’s reported $2.78 billion in sales in the quarter ending April 29, 2005. An estimated 60,000 LifePak 12 defibrillators are used worldwide.

Sources: Janet Moore, “FDA: Medtronic didn’t fix defibrillator flaws,” Star Tribune, June 22, 2005; “Medtronic gets FDA warning on defibrillators,” Bloomberg News, June 22, 2005.