BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4152400 · Received August 5, 2014

    Report

    Report Number
    3009448963-2014-00163
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 7, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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 THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM RECEIVED MULTIPLE SHOCKS. UPON REVIEW OF THE ELECTROGRAMS (EGMS) VENTRICULAR FIBRILLATION (VF) WITH INTERMITTENT UNDERSENSING WAS NOTED. IN THE FIRST EPISODE THREE SHOCKS WERE DELIVERED AND RHYTHM CONVERTED ON THE THIRD SHOCK. IN THE SECOND EPISODE TWO SHOCKS WERE DELIVERED WITH THE PATIENT'S RHYTHM CONVERTING ON THE SECOND SHOCK. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THE POTENTIAL REASONS FOR THE UNDERSENSING AND OPTIONS FOR PROGRAMMING WERE REVIEWED. SUBSEQUENTLY THE S-ICD WAS REPROGRAMMED WITH LOWER DETECTION RATES FOR THERAPY ZONES. AN X-RAY WAS PERFORMED AND FOUND THE GENERATOR IS AN ANTERIOR POSITION. ACCORDING TO THE FIELD REPRESENTATIVE THE PHYSICIAN DID NOT THINK PRODUCT PLACEMENT WAS A CONTRIBUTING FACTOR IN THE UNDERSENSING, HOWEVER THE CAUSE OF THE UNDERSENSING REMAINS UNDETERMINED. AT THIS TIME NO SURGICAL INTERVENTION IS PLANNED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456376 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 3010