BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4152538 · Received June 17, 2014

    Report

    Report Number
    3009448963-2014-00122
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE ELECTRODE INCISION WAS DEEMED INFECTION. THE HOSP BELIEVES THE PT HAD METHICILLIN-RESISTANT (B)(6). THREE COURSES OF ANTIBIOTICS WERE ADMINISTERED, BUT UNSUCCESSFUL. THE DEVICE AND ELECTRODE WERE DISPOSED OF BY HOSP STAFF AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355271 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 3010