Guidant defibrillators
The MHRA has issued three alerts after Guidant Corporation announced a worldwide recall of some of its implantable defibrillators and cardiac resynchronization therapy defibrillators, and issued warnings about more. The alerts affect almost 1600 devices distributed in the UK. These devices can develop an internal short circuit without warning, resulting in failure to deliver a live-saving shock when needed. There have been two deaths and forty-three failures suspected to be associated with this malfunction.
The affected models are:
- VENTAK PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
- CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
- CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
Guidant has also issued warnings about the following models affected by a software error potentially causing malfunction and battery depletion:
- VENTAK PRIZM AVT model 1900
- VITALITY AVT models A135 and A155
- CONTAK RENEWAL 4 AVT models M170 and M175
- CONTAK RENEWAL 4 AVT models M177 and M179
To date Guidant has confirmed that two failures have occurred in these models.
Guidant Corporation admitted in May 2005 that some of its internal cardiac defibrillator models are prone to short-circuiting and malfunction. The device, implanted in the chest under the skin, sends out electrical charges to shock a stopped or abnormally beating heart back into normal rhythm.
Although Guidant reported the problem to British doctors in May 2005, a number of newspaper reports have alleged that the corporation knew of the problem for more than three years.
Medtronic
In February 2005 Medtronic, another US based company, issued a public statement regarding its implanted defibrillators which can fail suddenly. Implantable defibrillators are a life saving device, used in the treatment of irregular heart rhythms, commonly known as arrhythmia. They work by monitoring the heart rate, sending electrical signals to the heart if it begins to beat too fast or too slow.
In 87000 devices worldwide, a battery defect resulting from damage during the manufacturing process has been detected. If the defect is present, rapid battery depletion may follow. This loss of power may occur without the knowledge of the subject, and at any time, even within the manufacturer's recommended follow up period. Complete loss of battery function can occur within a few hours. Battery failure in this way means the devices are unable to deliver the electrical jot that is needed if the user develops a potentially life threatening arrhythmia.
The batteries carrying the defect were manufactured between April 2001 and December 2003. Medtronic believe the overall risk of battery depletion is low and expect only 1 in 10 000 batteries will be affected. The MHRA has said that there are potentially 805 devices in the UK, with approximately 791 implanted and in use. So far, there have been no reports of injury or death as a result of the defect.
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