Defibrillators / cardioversors, implantable, Profile MD model V 의 안전성 경고

Safety alert

507

2002-03-20

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

In profile md model v cardioversion-defibrillators (icds), 33 nf ceramic capacitors may fail, leading to decreased reliability of the units. the manufacturer initiated the correction by technical memoranda sent to us physicians through federal express dated july 13, 2001. the company states that no death or serious injury occurred due to product failure. two different clinical manifestations of trainer failure can be observed, depending on the location of the trainers. products with a capacitor that fails in the high voltage module may exhibit a rapid loss of sensitivity or hypersensitivity of internally generated interference - or noise, resulting in failure or release of shocks. products with a capacitor that fails in the high voltage module may experience premature battery loss without other clinical manifestations. although the battery voltage may fall rapidly to a value close to or below the optional equipment reset indicator, it stabilizes for several months at a value that the product continues to detect arrhythmias and promote appropriate therapy. some of these products may also exhibit hypersensitivity of internally generated electrical interference or noise that may result in a false tachyarrhythmia detection, but interference decreases during loading and therapy is usually failed without releasing inappropriate shock to patients. these failures occur within 24 months of the date the modules were incorporated into the set of icds; products that have not failed within 24 months will not present a risk of failure at a later date.

Check receipt of the technical memorandum dated July 13, 2001 from St Jude Medical. The manufacturer states that none of the potentially affected ICDs that were not deployed remain on the market and that all units manufactured as of January 2001 are not affected by this problem. They estimate that the anticipated number of additional failures is less than 13. They claim that the decision to switch an ICDs prophylactically depends on clinical judgment. They add, however, that product switching should be considered for patients with products that have suspect trainers in the Low Voltage Module. St Jude will provide replacement products at no charge according to its warranty policy to any physician who decides to replace the products affected by this fix. Any patient who does not have their products changed should be monitored monthly in the remaining months during which additional failures may occur and then every 3 months. In the United States, increased monthly monitoring can occur using St Medical Housecall Transtelephonic Monitoring System with no burden during the 24 month period of remaining risk. For more information on specific patients or for more information regarding this correction, contact your local representative or directly with St Jude Medical's tachycardia technical service department at 1 (468) 474-4147, at U.S. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send by fax 0xx61-4481257