A defibrillator implanted in 24,000 people worldwide contains a design flaw that has caused some units to malfunction and short-circuit, Guidant Corp., a medical device maker, said in its May 23, 2005, letter to physicians. There have been 26 reports of failure including one death regarding these devices, the company said.
The problem is in Guidant�s VENTAK PRIZM 2 DR implantable defibrillators manufactured prior to November 2002. Devices manufactured after this date are not affected, the company said.
On May 24, 2005, the New York Times reported that Guidant sent the letter to doctors only after learning that it was preparing an article about the device. In addition, the New York Times said Guidant acknowledged that it had waited 3 years to tell patients and their doctors about the electrical problem found in the devices–because the �failure rate was very low and replacing the devices might pose greater patient risks.�
Patients with a VENTAK PRIZM 2 DR should consult with their physician if they have questions regarding their device, particularly if they have recently received a defibrillation shock. Guidant recommends that physicians continue monitoring patients every three months as described in the labeling. Guidant does not recommend early replacement of these devices. The company believes the overall device reliability remains high.
In December, Johnson & Johnson announced it plans to buy Guidant for 25.4 billion. On Tuesday, Johnson & Johnson, in a statement, reaffirmed its confidence in its decision to acquire Guidant and said it anticipates a closing of the transaction in the third quarter of 2005.
(via Business Wire)
{ 5 comments }
My sister has a defib and she is concerned that hers might be one of the “bad” one’s. Where can I get info on this. Have model, product and serial info.
If you have this device, I suggest you RUN dont walk to your nearest facility to get an “independent” evaluation of your device.
DO NOT RELY ON TECH’s WORDS THAT YOUR DEVICE IS WORKING AS IT SHOULD. THEY LIE!
WARNING: My fathers replacement device ALSO gave him great trouble. When he died shortly thereafter no autopsy was performed and his device much to our horror was later discovered by the family as being MIA!
Our father died in very short order of his replacement all due to a triple whammy and all credit goes to this device, its replacement and the subsequent and repeated administration of Natrecor in the end, (FYI: Natrecor is another one of Johnson and Johnson’s babies. If you take Natrecor please consider joining in the class action suit against the company. This drug kills!
No one or any amount of money via suit can ever mend our (his family’s) broken hearts. He was a victim, he was seriously mislead and he was abused. Now he is dead. 3/2005
On Sept 11, 2003 I had a Guidant Pacemaker replaced by a Guidant AICD Model A135, Serial No. 105532, Defibrillator. Can you advise if I should have any concern about this device?
I had a Guidant AICD Model A135, implanted 9 July 2003. Today, 20 June 2005 I had my regular 3 month check-up and my doctor was unaware of any problems with the unit! I left copies of the internet information I had downloaded. I don’t think anyone is in a hurry for this data to become public!!
I had a Vitality AVT A135 put in in October 2003. I was on the list to be reprogrammed. I did not find out about the problem from my doctors or Guidant . No letters.No phone calls. I became aware of the problem in middle of June one month after the doctors new. I found out from the newspapers and the internet. Several phone calls to Guidant returned no ewsults. The doctors didnot seem to have all the information either. Thank God for the internet. Needless to say I am very angry because of the lack of concern. Finally, one of the heart doctors made an appointment for me with a Guidant rep for reprogramming, I wanted to talk to a doctor first, but none of them were available for a meeting for one reason or another. I finally did get reprogrammed at the Hospitl, however it was with a lot of anxiety. How on earth do I know this will work? Maria
Comments on this entry are closed.