BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 4232371 · Received August 27, 2014

    Report

    Report Number
    3009448963-2014-00198
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING INDUCTION TESTING AT IMPLANT THERE WAS A 12 SECOND DELAY TO THERAPY AND CONVERSION WITH A 65 JOULE SHOCK. AFTER WAITING SIX MINUTES ANOTHER INDUCTION TEST WAS PERFORMED WHERE THERE WAS A 32 SECOND DELAY TO THERAPY. THE RHYTHM WAS CONVERTED WITH THE 65 JOULE SHOCK ON THE SECOND INDUCTION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND AN ELECTROGRAM (EGM) STRIP WAS SENT IN FOR REVIEW TO DETERMINE WHY THE INCREASED DELAY IN TIME TO THERAPY AFTER INDUCTION. UPON REVIEW, TS DETERMINED THAT TEN SECONDS POST INDUCTION THE PATIENT'S VENTRICULAR FIBRILLATION (VF) AMPLITUDE CHANGED AND REQUESTED A DISK OF THE DEVICE'S MEMORY BE SENT IN FOR REVIEW. THE DISK HAS NOT YET BEEN RECEIVED. THE DEVICE WAS IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518972 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 3010