BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4152458 · Received July 29, 2014

    Report

    Report Number
    3009448963-2014-00161
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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) AND ELECTRODE WERE IMPLANTED APPROX FOUR WEEKS AGO AND NOW THE PT HAS AN INFECTION. THE S-ICD SYSTEM WAS EXPECTED AND WILL BE REPLACED WITH A TRANSVENOUS SYSTEM ONCE THE INFECTION CLEARS. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441668 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R 1010