Medtronic Leads Fractured

October 19, 2007, 3:00PM. By Jane Mundy

Oahu, HawaiiMy husband David had a defibrillator installed in August, 2005 but the alarm started going off about a year later," says Sharon H. His doctor thought there was something wrong with the leads so ordered an x ray and discovered that the Medtronic lead had fractured. The Medtronic representative's response? "This never happens." Wrong answer, as many victims of fractured Medtronic leads can attest.

At first David didn't realize the alarm was going off because he is hard of hearing. But Sharon and David (not their real names) re-read the instructions and realized it must have been the alarm—it was going off at the same time every day.

"We called Medtronic and they told us to call our doctor first," says Sharon. "Our doctor thought there was something wrong with the leads and sent him for x rays. The Medtronic rep saw the x ray and still didn't quite believe what he saw—that the lead had a crack in it.

"My husband was really upset because the rep disconnected the alarm. Then we had to fly to Honolulu and see the surgeon who implanted it--he was furious because Medtronic said it was the surgeon's fault.

In August of 2006 Donald was scheduled for surgery, ostensibly to have the leads replaced. Instead the doctor capped the part of the lead that was fractured. We didn't realize that the lead was still in there and just capped off until a subsequent follow-up visit to the doctor. We were told that everything was fine.

Then in December of 2006-- while on holiday--the lead caused shocks which resulted in a trip to the emergency room and then a transfer to a cardiac hospital for lead replacement. Every time the shock went off, it was worse than the previous shock. The pain was getting worse and every time he moved, he received a bigger shock—it escalated.

We had to wait for the Medtronic rep to show up—apparently they have to be in on everything. 'I am going to rip this thing out myself if you don't turn it off right now,' I told the nurse in ER. She got a magnet, stuck it on the lead and it powered the whole unit down. Apparently she didn't have permission. 'I don't care what Medtronic or the doctor says,' she said. She was awesome. And she may have saved David's life.

The ER did not have the monitoring equipment to determine whether it was his heart or a malfunction. Medtronic told us that any ER would have the right equipment. Guess what? It didn't. The rep took two hours to arrive with the equipment to check the unit after the doctor called.

Then he had to go by ambulance to another hospital where the leads were finally taken out and replaced. The surgeon in Minnesota could hardly believe that the fractured lead was not replaced.

When David called Medtronic, he found out that this old and new lead is on the recall list! And now the cardiologist says Donald is suffering from post-traumatic stress. Every time he hears a loud noise or someone dropping something, he jumps."

"I had just about gotten back to normal when I read your article on the internet about the Medtronic recall," says David. "Now I am back to being paranoid about this. Also Medtronic has not notified me of the recall but I know that my surgeon in Minnesota is monitoring his patients every month."

"When we were trying to get reimbursed—up until March of this year-- Medtronic still said there was not a problem with these kinds of leads," says Sharon. When you call them, they don't give you any information—they just tell you to call your doctor. It is so frustrating it is enough to turn my hair gray."

Now that the leads have been recalled, Medtronic can no longer be in denial.