BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2161646 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-06769
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    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

    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 SYSTEM WAS EXPLANTED DUE TO INFECTION APPROXIMATELY EIGHT MONTHS POST IMPLANT. NO ALLEGATIONS AGAINST THE IMPLANTED PRODUCTS AND NO RETURN OF ANY EXPLANTED PRODUCT IS EXPECTED. THE PATIENT WAS REPORTED IN GOOD CONDITION AND ANOTHER SYSTEM IS TO BE IMPLANTED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention