VENTAK PRIZM 2 DR
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VENTAK PRIZM 2 DR

On Wednesday, December 14, 2005, the FDA announced that it has received reports of recent patient deaths linked to fatal complications in heart devices manufactured by Guidant Corporation.

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VENTAK PRIZM 2 DR

The Ventak Prizm 2 DRs are subject to a manufacturer defect of the wire insulator in the lead connector block. This defect may cause a short circuit in the electrical system which may prevent the device from providing therapy at the appropriate time. This defect appears in 26,000 devices manufactured before April 2002. There have been 28 instances of failure including one reported death due to this malfunction, and over 17,000 of these devices built before April 2002 are still in service. Any patients with these devices or those who have received a defibrillation shock are advised to contact their physicians immediately.

Ventak Prizm 2 DR | Contak Renewal | Ventak Prizm AVT | Vitality AVT | Renewal 3 AVT | Renewal 4 AVT

 
 
 
 

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