Sterile packaging containing 01 Cardioversor Implantable Defibrillator Belos VR (VVIRD) and accessories: wrench, silicone glue, mineral oil. 의 안전성 경고

Safety alert

721

2003-06-02

Brazil

ANVISA

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

Through letter, biotronik informed the doctors who make the evaluations of the patients involved in the cardioversors defibrillators beautiful vr. this measurement is necessary after it has been detected that there may be a defect in the high voltage capacitors of a specific production batch and that, in particular cases, can lead to non-loading of the programmed shock energy after the maximum charge time of 16 seconds. in addition, it has been observed that some capacitors have a prolonged charge time which is still within the range of 16 seconds. in these cases, these capacitors are not being reformed as often as needed. the reforms will again reduce the load times to the expected values.

BIOTRONIK recommends scheduling an immediate evaluation with these patients. For this purpose, the following suggestions were prepared to be followed during this clinical evaluation: 1 - On the shock list, examine the loading times for capacitor therapies and reforms. If any charging time is 16 seconds or if any power shows "???", the generator should be replaced immediately because the programmed power may not have been delivered. 2- If the generator is not recommended for replacement in item 1, use the I-K04.0.A / 1 software, which was specially designed to carry out a total of 10 capacitor changes (two with 20J, two with 25J and more 6 with 30J). The time required to complete this process will be approximately 8 minutes, with the impression of the list of shocks at the end. If any of the 10 charging times is 16 seconds or if any power value shows "???", the generator should be changed immediately because the charged power may not be the programmed power. 3- If the generator is not recommended for replacement in item 2, we recommend scheduling automatic capacitor reforming every 3 months. Patients should then follow their routine assessments. If a Belos VR generator is exchanged for the reasons explained in this notice, BIOTRONIK will offer a generator for exchange compatible with its warranty term.