BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2050559 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04170
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 THE PATIENT EXPERIENCED SWELLING IN THE LEFT ARM AND HAND ONE DAY POST IMPLANT. A THROMBOSIS IN CLOSE ASSOCIATION WITH THE PACER ELECTRODE WAS CONFIRMED THROUGH DIAGNOSTIC IMAGING, ALTHOUGH THE SPECIFIC LEAD WAS NOT IDENTIFIED. THE PATIENT WAS PLACED ON A COUMADIN REGIMEN FOR SIX MONTHS. THE SYSTEM REMAINS IN SERVICE.

    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 64 YR Life Threatening| R 4543| 0185| N119| 4470