BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951463 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22885
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 9, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 FROM THE LOCAL REPRESENTATIVE THAT THIS DEVICE AND LEAD SYSTEM WERE SUCCESSFULLY EXPLANTED APPROXIMATELY 1-2 WEEKS AGO DUE TO INFECTION. A COMPETITOR LOCAL REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE AND IT WAS NOT KNOWN IF THE EXTRACTED SYSTEM WILL BE RETURNED OR WAS DISPOSED OF BY THE HOSPITAL STAFF. SUBSEQUENTLY, A REPLACEMENT DEVICE AND LEAD SYSTEM WERE SUCCESSFULLY IMPLANTED.

    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 75 YR Hospitalization| L| R 0185| 4470| N119| H170| 4543| MISMATCH