BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2040042 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00271
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    September 27, 2010
    Report Date
    January 5, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    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 THAT APPROXIMATELY THREE MONTHS POST IMPLANT, THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD DEVELOPED A POCKET INFECTION. A REVISION PROCEDURE WAS PERFORMED, THIS LEAD WAS REMOVED. A REPLACEMENT PROCEDURE WILL BE PERFORMED WHEN THE INFECTION HAS HEALED. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0165

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 0165| N107| MISMATCH| 4316| H197