BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 5131977 · Received October 7, 2015

    Report

    Report Number
    3009448963-2015-00579
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 8, 2015
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    UDI-DI
    00802526562808
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THE SUBCUTANEOUS THE PATIENT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM WAS TRYING TO MOVE SOMETHING WHEN SHE BUMPED THE LOCATION OF HER IMPLANTED SYSTEM WHICH CAUSED THE SUTURES TO TEAR OUT OF THE MUSCLE. THIS CAUSED BOTH THE PULSE GENERATOR AND ELECTRODE TO MOVE OUT OF POSITION. AN X-RAY WAS TAKEN AND IT WAS DEEMED NECESSARY TO PERFORM A REVISION. DURING THE REVISION, THE PHYSICIAN ATTEMPTED TO PERFORM DEFIBRILLATION THRESHOLD (DFT) TESTING, HOWEVER THEY WERE UNABLE TO INDUCE THE PATIENT WITH THE PRODUCTS IN THE MIGRATED POSITION. THE PRODUCTS WERE BOTH REPOSITIONED AND DFTS WERE SUCCESSFUL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661664 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010 00802526562808

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R