Summary

Original source:
http://www.medgadget.com/archives/2005/06/guidant_recalls.html

Details

• Here's another similarity between medical devices and cars: both can have recalls.
• This weekend, tens of thousands of patients with Guidant defibrillators (such as the Ventak Prism 2 DR) were informed that their devices could short-circuit.
• Several people with Guidant units said that when they heard about the troubled implants they reached into their wallets and pulled out a card that identifies the make and model of the device they carry inside.
• For those who found a match, the feeling was quick and sinking.
• "My first reaction was a little bit of panic," Mr. Parsons said.
• The surgery to replace a defibrillator, which is the size of a pager and is implanted under the skin of the upper chest near the shoulder, takes an hour, and many people go home immediately afterwards.
• But like any surgical procedure, the surgery carries a risk of infection.
• For many, the risk of surgery and infection outweighs the potential for catastrophic failure.
• But it's an unpleasant choice to have to make.
• And this Guidant situation is unusual because the company knew about the defect but didn't disclose it -- thousands of faulty devices were knowingly sold and implanted.

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