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i have the sprint lead 6949
i am 21 years old and i have the recalled lead 6949 i had an alarm put on it but when they did it i could not hear the alarm. i am worried about it going off and not hearing it. every day i stress about it fracturing and i dont know what to do about it i am only 21 i dont need this stress everyday what can i do abou this recall.
2 Comments
I'm dealing with it @ 57
by kmcgrath - 2008-01-23 03:01:24
Howdy,
I've got one of the recalled leads but I guess I'm lucky in that I'm able to not worry about it too much. My EP doctor told me that even though it was recalled the probability is still very low that anything will happen. They turned my alarm on but with my hearing in my left ear I doubt I will hear it unless things are unusually quiet or I'm near someone with good hearing. They also gave me a home monitor that sends in my ICD status once a month and I'm now seeing my EP doctor once every two months. I'm sure your mileage may vary but I'm able to not think about this too often so I can only suggest that you keep talking with your doctor and try and not worry about it as much as possible. You could also take the risk and insist that they replace the leads ASAP but that's your call.
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Recalled Leads
by SMITTY - 2008-01-21 11:01:28
Below is a little information on the recalled leads you may find interesting if you haven't already seen al this.
My advice is contact your doctor again and state your concerns, or just put those concerns in writing and send them to your doctor. Send a copy to the hospital administrator where you received the lead. If you get no satisfaction in a day or two, contact Medtronic and tell them your concerns. If you feel you are not getting the attention you need, call the phone number shown at the bottom of his page.
Good luck.
Recalled Models
Four models were included in the Medtronic recall. They include Sprint Fidelis model numbers:
6930
6931
6948
6949
Patients who have been implanted with one of the recalled Medtronic models are urged to consult with their physician to determine whether or not the part needs to be replaced. Replacement surgery is dangerous, and most doctors will re-program the device rather than replace it. However, in cases where the device is not functioning properly, a patient may have no other option but replacement.
Device Defect Prompts Medtronic Recall
According to the Food and Drug Administration, the Medtronic recall was prompted by reports of lead fractures, a problem that could cause the lead to misread heart signals. Leads are medical devices that connect the heart to defibrillators, which are used to treat patients who have abnormal heart rhythms.
The Medtronic recall does not affect defibrillator devices themselves or pacemakersonly Sprint Fidelis electrical leads.
Patient Risk
Although Medtronic said the risk to patients is relatively small, thousands of patients may experience a lead malfunction. More than 230,000 patients have been implanted with a Sprint Fidelis lead, and the company said as many as 5,000 may suffer a lead fracture less than three years after the initial implantation.
Your Legal Rights
A malfunctioning lead can cause serious injury and even death. If you suffered a Medtronic lead malfunction, or your loved one died as a result of a faulty Medtronic heart device, its important to understand that you have legal rights.
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