U.S. halts shipment of heart devices> Firm criticized for faulty pacemakers

WASHINGTON — The government halted U.S. production by the world’s third-largest pacemaker manufacturer Friday, citing problems that could put heart patients at risk.

The Food and Drug Administration accused Telectronics Pacing Systems of failing to investigate failures of heart devices, including a potentially faulty pacemaker wire implanted in 22,000 Americans, so that problems could be corrected.

However, the consent decree, one of the FDA’s most severe sanctions, doesn’t say that any of Telectronics’ manufacturing violations specifically hurt a patient.

“The injunction is aimed at preventing problems,” said FDA spokesman Jim O’Hara. “Without quality control measures in place, companies cannot assure the FDA or the public that their devices are safe or work as intended.”

The consent decree prevents Englewood, Colo.-based Telectronics from making and shipping heart devices to U.S. doctors until the company corrects the violations. But hospitals that already have Telectronics devices in stock may continue to use them in patients.

“The company’s going to move forward as quickly as it can to come into compliance,” said Telectronics spokesman Wayne Pines. “We can reassure physicians and patients that Telectronics products are reliable. The issues are serious but they involve manufacturing issues.”

Telectronics made headlines in January when it issued a worldwide recall of a potentially faulty pacemaker wire implanted in some 40,500 people, including 22,000 Americans.

The “J” wire, which delivers electric pulses to keep the heart beating regularly, sometimes breaks and punctures a patient’s heart. It is blamed for two patients’ deaths and at least a dozen injuries. Also, about 1,000 patients have had surgery to remove the defective wire and four have died during that operation.

Lawsuits accuse Telectronics of not warning patients about the malfunctions until January even though it received the first reports last fall.

The FDA, in an August inspection and an October warning letter, said Telectronics had not properly investigated reports of patient injuries or reported them to federal authorities.

FDA court documents don’t specifically mention the “J” wire, but reiterate that Telectronics repeatedly violated those federal regulations despite pledges to FDA to correct the problems.

The documents detail violations dating back to 1993.

Medical device companies are required to investigate doctor complaints when such devices malfunction, to ensure a manufacturing error wasn’t to blame.