BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1871678 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-19793
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS CONFIRMED THIS DEVICE DECLAIRED END OF LIFE (EOL) DUE TO CHARGE TIME OUT, WHICH WAS THE RESULT OF A BLOWN PLASMA FUSE. ANALYSIS ALSO CONFIRMED THAT THE DEVICE DID DELIVER 3 FULL ENERGY SHOCKS, BUT DURING THE 3RD SHOCK THE DEVICE HAD SHORTED LEAD. IT APPEARS THAT THE LEAD(S) WERE BAD WHICH CAUSED THIS DEVICE TO HAVE A SHORTED LEAD EVENT. THIS CAUSED THE PLASMA FUSE TO OPEN, AND WAS UNABLE TO DELIVER ANY FURTHER SHOCKS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT, WHO HAS THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), HAD A GALLBLADDER OPERATION, AND THE PHYSICIAN WAS WORKING WITH MAGNETIC SUPPORT. THE PATIENT WAS IN THE HOSPITAL RECOVERING FROM THE GALLBLADDER SURGERY WHEN HE/SHE RECEIVED THREE SHOCKS DUE TO EXPERIENCING VENTRICULAR FIBRILLATION (VF). SHORTLY AFTER, THIS PATIENT AGAIN WENT INTO VF, BUT NO THERAPY WAS DELIVERED. THE PHYSICIAN HAD TO USE EXTERNAL SHOCKS TO CONVERT THE ARRHYTHMIA. DURING DEVICE INTERROGATION, A WARNING MESSAGE WAS DISPLAYED. THERE IS AN ALLEGATION OF PREMATURE BATTERY DEPLETION, AND A SAVE TO DISK IS BEING SENT INTO BOSTON SCIENTIFIC TECHNICAL SERVICES (BSC TS) TO BE REVIEWED. THIS PATIENT REMAINS IN AN UNSTABLE CONDITION, AND THIS DEVICE WAS PROGRAMMED TO MONITOR ONLY (MO). SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT A REPLACEMENT PROCEDURE TOOK PLACE FOR THIS ICD AND ASSOCIATED LEAD. THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1