Maker Of Recalled Pacemaker Is Advising Doctors, But Not Patients
WASHINGTON (AP) _ The maker of a recalled pacemaker is now writing cardiologists to say which patients are at risk from the potentially faulty device and how they should be treated.
But Telectronics Pacing Systems Inc. said Wednesday that it won’t publicize the advice _ even to concerned patients calling the Colorado firm _ until doctors get the letters for fear patients won’t understand without expert help.
The latest the company will complete and mail those letters is Jan. 27, although it hopes to finish sooner, said Vice President Larry Wettlaufer.
At issue is a wire that connects the heart wall with the pacemaker, which sends electronic pulses to regulate heartbeats. Called a J-wire because of its shape, it was implanted in 40,500 people worldwide, including 22,000 Americans.
Telectronics recalled unimplanted wires from hospitals last fall, after two deaths occurred when the wire poked through its insulation. Eleven other patients with similar wire problems all recovered.
The Food and Drug Administration had expected to announce patient advice Wednesday, but at the last moment, it agreed to wait for Telectronics to notify doctors first.
The letters will recommend that doctors contact all patients with the wires, formally called the Accufix atrial ``J″ models 701 and 801, and discuss their risk of wire fracture. Patients then will be counseled and monitored, Wettlaufer said, but he declined to elaborate.
``This is a manageable situation,″ he said.
Meanwhile, of several thousand concerned patients who have called the company for information in the last week, only a small percentage even have the wire, Wettlaufer said.
Doctors can tell concerned patients if they have the wires using information on the implant cards that all pacemaker recipients receive after surgery.