Medtronic Heart Defibrillator Lead Recalled
10.15.07: Medtronic stops sales of the Sprint Fidelis lead, a wire that connects the defibrillator to the heart, after it was determined the leads may be prone to developing hairline fractures resulting in defibrillator malfunction.
Background
Medtronic has stopped selling the fracture prone leads and has announced the recall of all leads not yet implanted. An estimated 235,000 patients who have received a Medtronic defibrillator since 2004 may be affected. A fracture in the lead wire may result in the defibrillator either delivering an unnecessary and painful shock to the heart, or failure to deliver the necessary shock to restore proper heart rhythm.
Medtronic estimates that about 4,000 - 5,000 people would experience lead fracture within 30 months of implantation requiring a risky surgical procedure to replace the defective lead. Medtronic claims that defibrillators can be re-programmed to mitigate the potential for problems and that they will contribute up to $800 worth of medical costs not covered by insurance. However they will not cover the cost of replacing a functioning lead, so the patient is left to pay that bill to know that the device they have will function correctly.
Earlier this year, Dr. Robert G. Hauser of the Minneapolis Heart Institute published data that revealed defibrillators fitted with the Fidelis leads were firing inappropriately, delivering painful jolts to the patient. He brought his findings to Medtronic, which admitted that while the data was inconclusive, it was troubling. The manufacturer issued a letter to doctors in March.
Patients should also be aware that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic.
What are defibrillator leads?
Defibrillators are small devices that are implanted into a patient’s chest that monitor their heart rhythm and provide an electrical shock when the rhythm is abnormal. The defibrillator lead, a small wire, attaches the device to the heart. Any problems that are encountered with leads are very serious as removing or replacing the leads requires risky surgery. A fracture in the lead wire may result in the defibrillator either delivering an unnecessary and painful shock to the heart, or failure to deliver the necessary shock to restore proper heart rhythm.
Additional Information:
What can I do?
If you have experienced any adverse effects from a Medtronic heart defibrillator, you should immediately consult your physician. You may also want to consider your potential legal claim. If you would like more information, click here to fill out a free case review form or contact attorney Ron Goldser directly, toll-free at 800.755.0098. Zimmerman Reed is experienced in handling defective medical device cases and we welcome any questions you may have.
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