BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4801153 · Received May 26, 2015

    Report

    Report Number
    3009448963-2015-00302
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 11, 2015
    Manufacturer
    CAMERON HEALTH INC.
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    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 THAT THIS PATIENT'S SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION AND INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED. THE ELECTROPHYSIOLOGIST THOUGHT THE INFECTION MAY BE RELATED TO A SKIN ISSUE AS THE PATIENT PREVIOUSLY HAD A TRANSVENOUS SYSTEM EXPLANTED DUE TO INFECTION AS WELL (FDA REPORT # 2124215-2014-17881, 2124215-2014-17883, AND 2124215-2014-17882). THE PRODUCTS WILL NOT BE RETURNED AS THEY WERE SENT TO PATHOLOGY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339644 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH INC. 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 3010