BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4770920 · Received May 12, 2015

    Report

    Report Number
    3009448963-2015-00278
    Event Type
    Injury
    Date Received
    May 12, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 16, 2015
    Manufacturer
    CAMERON HEALTH INC.
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE PATIENT WAS HOSPITALIZED DUE TO SEPSIS WHICH WAS THOUGH TO HAVE BEEN CAUSED BY A HEMODIALYSIS SHILEY CATHETER. BLOOD CULTURES WERE TAKEN WHICH CAME BACK POSITIVE. THE PATIENT WAS ON A VENTILATOR AND GIVEN INTRAVENOUS ANTIBIOTICS. IT WAS FURTHER NOTED THAT THE PATIENT RECEIVED TWENTY INAPPROPRIATE SHOCKS AS A RESULT OF T-WAVE OVERSENSING DUE TO A CHANGE IN AMPLITUDE. TACHYCARDIA THERAPY WAS PROGRAMMED OFF FOR A FEW DAYS AND THEN REPROGRAMMED BACK ON. THE PATIENT REMAINS HOSPITALIZED WITH A FEVER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310471 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH INC. 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| L| R 3010