BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1951509 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23101
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 28, 2010
    Report Date
    February 28, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN TO OUR POST MARKET QUALITY ASSURANCE LABORATORY, INITIAL VISUAL INSPECTION NOTED THERE WAS AN ELECTRICAL ARC MARK ON THE DEVICE CASE IN FRONT OF THE HEADER PORTS. X-RAY INSPECTION VERIFIED THAT THE DEVICE'S INTERNAL FUSE WAS STILL INTACT. REVIEW OF DEVICE MEMORY INDICATED THAT THE DEVICE HAD SHOCKED INTO A SHORTED LEAD CONDITION ON THE THIRD ATTEMPT OF AN EPISODE FROM THE DATE OF THE CLINICAL OBSERVATIONS, WHICH RESULTED IN A SHORTED LEAD FAULT. A COMMANDED SHOCK WAS SUCCESSFULLY PERFORMED DURING BENCH TESTING, WHICH VERIFIED THAT THE DEVICE WAS ABLE TO DELIVER TACHYCARDIA SHOCK THERAPY. SUBSEQUENT TESTING AND ANALYSIS INDICATED THAT AN OPEN ELECTRICAL CONDITION EXISTED IN THE DEVICE'S LEAD SWITCH PACING CIRCUITRY AND BRADYCARDIA THERAPY WAS NO LONGER AVAILABLE. OUR ANALYSIS COULD NOT IDENTIFY A ROOT CAUSE FOR THIS CONDITION: THIS TYPE OF DAMAGE TO THIS CIRCUIT USUALLY RESULTS FROM THE DELIVERY OF EXTERNAL DEFIBRILLATION SHOCKS, AS THE COMPONENTS ARE RATED AT A VOLTAGE SIGNIFICANTLY HIGHER THAN THE SHOCKS DELIVERED BY THE DEVICE; HOWEVER, IT WAS REPORTED THAT THE PATIENT HAD NOT RECEIVED ANY EXTERNAL SHOCKS. NO OTHER DEVICE ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEAD ARE TO BE RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS NEWLY-IMPLANTED DEVICE AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED DUE TO AN INDICATED SHORTED SHOCKING CONDITION DURING DEVICE INTERROGATION AFTER THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPIES. IT WAS REPORTED THE PATIENT, WHO ALSO WAS ON A VENTILATOR, INITIALLY EXPERIENCED A VENTRICULAR TACHYCARDIA (VT) BELOW THE PROGRAMMED THERAPY ZONES TWO DAYS AFTER DEVICE IMPLANT. FOLLOWING DEVICE REPROGRAMMING, THE PATIENT EXPERIENCED SEPARATE VT EPISODES WITH THERAPY DELIVERY THAT SUCCESSFULLY CONVERTED THE ARRHYTHMIAS. DURING ONE EPISODE, THE DEVICE RECORDED A LOW OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) REVIEWED THE AVAILABLE INFORMATION AND EPISODE ELECTROGRAMS, AND RECOMMENDED DEVICE AND LEAD REPLACEMENT DUE TO THE LIKELIHOOD OF DEVICE DAMAGE AND POSSIBILITY OF AN INTERMITTENT LEAD ANOMALY. IT WAS SUSPECTED THE LEAD MAY HAVE BEEN DAMAGED DURING IMPLANT DUE TO TORTUOUS PATIENT ANATOMY. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED; THE PATIENT WAS SUCCESSFULLY UPGRADED TO A DUAL-CHAMBER DEVICE DUE TO HAVING ACQUIRED COMPLETE HEART BLOCK. THE PATIENT SUBSEQUENTLY PASSED AWAY AFTER MEDICAL STAFF EXPERIENCED DIFFICULTY MANAGING THE PATIENT'S BLOOD PRESSURE WITH MULTIPLE MEDICATIONS, AND A FAMILY MEMBER ELECTED TO CHANGE THE PATIENT'S STATUS TO DO NOT RESUSCITATE. THERE WERE NO ALLEGATIONS AGAINST THE DEVICE IN ASSOCIATION WITH THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other| R 0158| E102