BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041297 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03768
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PROVIDED SHOCK THERAPY FOR WHAT WAS BELIEVED TO BE AN ATRIAL BASED RHYTHM. A CHEST X-RAY FOUND THE LEADS WERE REVERSED IN THE HEADER. THE POCKET WAS REOPENED AND THE LEAD PINS WERE REMOVED AND REINSERTED INTO THE PROPER POSITION IN THE HEADER. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143975 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| L| R T180| 0184| 4469| E102