Medtronic’s recent recall of their
Sprint Fidelis defibrillator leads has caused panic for many of the patients who have the leads implanted. That panic may be even greater for some patients who had their Medtronic defibrillator
device recalled in 2005.
The system
A defibrillator is a small device that is surgically implanted into a patient’s chest that monitors their heart rhythm and provides an electrical shock if that rhythm becomes irregular. The defibrillator lead (the Sprint Fidelis model that is the subject of the recent recall) is also implanted into the patient’s chest and connects the defibrillator itself to the heart. It is basically a small, thin wire that allows the heart and the defibrillator device to communicate with each other.
The problem
Over 250,000 patients may be subject to Medtronic’s Sprint Fidelis recall (model numbers 6930, 6931, 6948 and 6949) – and many of them are just plain angry – especially after learning that the problem could have been avoided.. Hospitals and doctors have come forth saying that they told Medtronic and the Food and Drug Administration (FDA) that the leads may be defective as early as January of 2006, but neither Medtronic nor the FDA reacted.
On October 15, 2007, Medtronic recalled the leads after it discovered that several patients were being unnecessarily shocked due to the product’s alleged defect. Those were the lucky ones. The defibrillator leads may have also been the cause of at least five deaths because instead of providing unnecessary shocks – they didn’t provide any shocks when they were needed.
Double whammy
Medtronic recalled some of its defibrillators back in 2005 because of faulty battery issues. Patients who were subject to the 2005 recall and now the 2007 recall have just cause to be upset as a ‘recall’ in these cases doesn’t mean taking something back to a store – it means undergoing invasive surgery. One patient reported that the emotional distress he’s been under about this has been ‘overwhelming’ and that he just doesn’t understand why the product wasn’t tested more thoroughly or pulled off the market sooner.
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