BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 3801680 · Received April 25, 2014

    Report

    Report Number
    3009448963-2014-00042
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 THE PT PRESENTED AT THE OFFICE FOR EVALUATION OF DRAINAGE FROM SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) POCKET/INCISION AREA. THE POSTERIOR EDGE OF THE DEVICE WAS ERODING THROUGH THE SKIN. THE PT WAS ADMITTED TO THE HOSPITAL AND THE S-ICD SYSTEM WAS EXPLANTED. THE PT WAS ADMINISTERED ANTIBIOTICS. NO ADD'L ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250328 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R 3010