BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1945590 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19871
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF NEW INFORMATION IS RECEIVED, THE EVENT WILL BE REOPENED AND FURTHER UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ENTIRE IMPLANTED SYSTEM WAS REMOVED DUE TO INFECTION; IMPLANT DURATION APPROXIMATELY 7 MONTHS. NO ADVERSE PATIENT EFFECTS REPORTED AND NONE OF THE REMOVED PRODUCT, WILL BE RETURNED FOR POST MARKET EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention