BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 3252171 · Received July 25, 2013

    Report

    Report Number
    3009448963-2013-00090
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 5, 2013
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO AN EROSION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347549 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR-PROD LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R