Medtronic Suspends Sale of Heart Device

Medtronic Suspends Sale of Heart Device

The Associated Press
Monday, October 15, 2007; 6:42 AM

WASHINGTON -- Medtronic Inc. has suspended distribution of its Sprint Fidelis defibrillation leads after identifying five patient deaths in which a lead fracture may have been a contributing factor.

A defibrillator monitors a patient's heartbeat; if it senses an abnormal heart rhythm, it delivers an electronic shock to reset the heart to a normal beat. A defibrillation system consists of a device implanted near the shoulder with one or more leads connecting the device to the heart.

Medtronic said Monday it had discovered a "small chance of fractures in particular locations" on Sprint Fidelis models 6930, 6931, 6948 and 6949. The company is asking doctors to stop implanting the leads and return all unused leads to Medtronic.

A fractured lead "can cause the defibrillator to deliver unnecessary shocks or not operate at all," said Daniel Schultz, director of the Food and Drug Administration's Center for Devices and Radiological Health.

The company is not recommending that patients with such a lead have it removed, since they "are more likely to experience complications from removal." Instead, Medtronic said, doctors can reprogram the device to alert the patient that a fracture may have occurred. Possible indicators could include audible alerts or inappropriate shocks.

"We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect," Schultz said. "However, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized."

More than 268,000 of the leads have been implanted. Medtronic and the FDA estimated that fractures have occurred in less than 1 percent of those leads.

Medtronic senior vice president Pat Mackin emphasized that the company's action does not apply to Medtronic pacemakers.

Medtronic advises patients with Sprint Fidelis leads to contact their doctor's office. Patients who are unsure about whether they have a Sprint Fidelis lead can contact Medtronic Patient Services at 1-800-551-5544, extension 41835, or visit http://www.medtronic.com/fidelis.

6 Comments

Holy Smokes!

by ela-girl - 2007-10-15 02:10:05

Thanks for posting this information. I don't have an ICD or even a Medtronic product, but I'm always interested in current news regarding cardiac devices. Although the percentage of lead fractures is small here, I couldn't help being a little scared and frustrated if I were a patient with these leads. I pray that many of us stay blessed with defect free devices!

ela-girl

PS: By the way, has anyone heard from Whitman Family recently? I wonder how she is doing and if she has gotten any more answers regarding the death of her husband.

Call Your Doctor

by kmcgrath - 2007-10-15 03:10:41

I placed a call to my EP Doc as soon as I read about this today and their office told me that they will be notifying affected patients as soon as they get notified by Medtronic, which could be as early as tomorrow.

I was told if they don't call me then no news is good news in this instance.

Letter to Dr's

by kyle0816 - 2007-10-15 04:10:59

Apparently Medtronic sent a letter out to physicians about the problem with the leads in late march, advising them not to be used. I had mine implanted in mid-April and if I have the leads in question I'm going to be more than angry.

Oh No....

by blogsdon - 2007-10-15 08:10:40

Hey I have that 6949 lead. Should I call my Dr. to see if they are going to program the ICD for the notification for the broken lead or are they to call me?

Thanks

Brian

I have it

by YellowMonkee - 2007-10-15 08:10:55

I just had mine checked today. I have the lead in question. The icd was programed to detect any problems with the leads, but they reprogramed it so it would detect more "minor" problems with the leads. They even made it give an alarm so I would know what it sounded like. They said if there is ever any problems, i would hear the alarm at 8:20 in the morning. And I would hear it ever morning at 8:20 until I went in to see the doc.

Call Medtronics First IMHO

by kmcgrath - 2007-10-17 03:10:54

Howdy,

You may want to call Medtronic first at the below number and let them tell you if your lead is impacted or not as when I called my EP Doctor's office they initially told me I wasn't on their list from Medtronic but then they called me right back to say that I was on their list.

In any event I was told to wait until my next scheduled appt., which is on 11/9, and they will do what they need to do at that time. As this will be my third trip to the EP's office to have my ICD checked since it was implanted in mid-April of this year, that seems a reasonable thing for them to do.
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Medtronic advises patients with Sprint Fidelis leads to contact their doctor's office. Patients who are unsure about whether they have a Sprint Fidelis lead can contact Medtronic Patient Services at 1-800-551-5544, extension 41835, or visit http://www.medtronic.com/fidelis.

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