BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1852033 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14702
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    May 6, 2010
    Report Date
    July 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CHRONIC TRANSVENOUS DEFIBRILLATION LEAD COULD NOT BE INSERTED INTO A COMPETITIVE DEVICE DURING A REPLACEMENT PROCEDURE. THE PATIENT REPORTED THAT THE COMPETITIVE DEVICE REMAINED IMPLANTED BUT NOT IN SERVICE. THE LEAD ALSO REMAINED IMPLANTED BUT NOT CONNECTED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening 0158| 4470| 1861| MISMATCH