This may or may not havre a y2k connection--the report does not state the cause of this malfunction-- but it is the sort of problem we were warned about prior to CDC.

Company Warns Doctors of Possible Pacemaker Problem

By Karren Mills Associated Press Writer

MINNEAPOLIS (AP) - The nation's second largest pacemaker manufacturer said Wednesday at least 90 of its pacemakers being used by heart patients could malfunction and stop emitting the electrical signal that regulates their heartbeat.

Problems had been reported in 33 of St. Jude Medical Inc.'s 35,000 Affinity pacemakers, spokesman Peter Gove said. Of the 891 pacemakers that St. Jude has identified as potentially having the problem, about 90 are affected, Gove said.

He said the company was unaware of any patient injuries, and the problems weren't severe enough to warrant immediate removal. The company, which is based in Little Canada, Minn., did send letters to doctors to inform them of the problem.

"For the vast majority of patients, all their doctor will do is continue to monitor them. If the problem presents itself, they will then decide whether to replace the pulse generator," Gove said.

The model numbers are 5130, 5230 and 5330.

The pacemaker is implanted in a pocket under the skin in the pectoral muscle. Gove said replacing the pulse generator typically is outpatient surgery and the company would pay up to $800 of any patient's unreimbursed medical expenses for replacing it.

The U.S. Food and Drug Administration has been advised of St. Jude's letter to doctors, Gove said.

Pacemakers help patients with slow heartbeats. Normally the condition is not life-threatening. However, a small number of patients are dependent on their pacemakers and could die if the device stops working. About 300,000 St. Jude pacemakers are in use in the United States.

Link:

http://ap.tbo.com/ap/breaking/MGIFVFH9R4C.html

-- Carl Jenkins (Somewherepress@aol.com), February 16, 2000

Answers

A bit more info, Carl. Yep, Y2k experts predicted this. Spinmeisters denied it, and here we are....

Doctors Warned of Pacemaker Problems

LITTLE CANADA, Minn. (AP) -- St. Jude Medical Inc. has informed doctors that a small number of its Affinity model pacemakers could malfunction and stop emitting the electrical signal that regulates a patient's heartbeat.

St. Jude said 33 of the its 35,000 Affinity pacemakers have been reported having problems, though the company is unaware of any patient injuries, spokesman Peter Gove said Wednesday.

Of the 891 pacemakers -- 640 in the United States -- that St. Jude has identified as potentially having the problem, the company believes about 90 are affected, said Gove.

That leaves about 60 pacemakers that may exhibit the problem within the next two years, he added.

"For the vast majority of patients, all their doctor will do is continue to monitor them. If the problem presents itself, they will then decide whether to replace the pulse generator," Gove said.

The pacemaker is implanted in a pocket under the skin in the pectoral muscle. Gove said replacing the pulse generator typically is outpatient surgery. The company said it would pay up to $800 of any patient's unreimbursed medical expenses for any such surgery. The U.S. Food and Drug Administration has been advised of St. Jude's letter to doctors, said Gove, adding that no recall order has been issued.

Pacemakers help patients with slow heartbeats -- a condition known as bradycardia. Normally the condition is not life-threatening. However, a small number of patients are dependent on their pacemakers and could die if the device stops working.

St. Jude Medical is nation's second largest pacemaker manufacturer, behind Medtronic Inc. About 300,000 St. Jude pacemakers of all types are in use in the United States, Gove said. (PROFILE (CO:Saint Jude Medical Inc; TS:STJ; IG:MTC;) (CO:Medtronic Inc; TS:MDT; IG:MTC;) ) AP-NY-02-16-00 1347EST

Source: News Day

http://www.newsday.com/a p/rnmphs0p.htm

-- Lee Maloney (leemaloney@hotmail.com), February 22, 2000.