This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device's delivery of a shock may have contributed to unintentional induction of or acceleration of an arrhythmia.Please refer to the incident description for more information regarding the specific circumstances of this event.
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It was reported that during induction testing with this subcutaneous implantable cardioverter defibrillator (s-icd) there was difficulty encountered.During the attempted induction the patient would go back to a normal sinus rhythm very quickly.In attempt to induce ventricular fibrillation (vf), atrial fibrillation (af) was unintentionally induced due to telemetry noise.The shock was unable to be aborted, therefore an inappropriate shock was delivered.This system remains in service.No adverse patient effects were reported.
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