BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040645 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00446
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 DEVICE AND RIGHT VENTRICULAR (RV) LEAD CAUSED A RED ALERT TO BE DETECTED DUE TO HIGH SHOCK IMPEDANCES GREATER THAN 125 OHMS. THE PATIENT'S PHYSICIAN IS AWARE OF THE SITUATION AND THE PATIENT WILL BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143786 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening