BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042470 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02053
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM DISPLAYED HIGH, OUT OF RANGE PACING IMPEDANCES AND NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL ONE DAY POST IMPLANT. A REVISION PROCEDURE WAS PERFORMED. THE POCKET WAS OPENED AND THE LEAD WAS CHECKED WITH A PACING SYSTEMS ANALYZER. THE RESULTING MEASUREMENTS WERE NORMAL. THE LEAD WAS THEN REATTACHED TO THE PULSE GENERATOR AND OPERATED AS EXPECTED. THE LOCAL FIELD REPRESENTATIVE (FR) REPORTED THAT THE LEAD HAD NOT BEEN FULLY INSERTED INTO THE HEADER DURING THE INITIAL IMPLANT. A SMALL HEMATOMA WAS NOTED IN THE POCKET AND WAS EVACUATED AT THE TIME OF THE REVISION PROCEDURE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. 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 71 YR Life Threatening| R 4136| 0185| N119| MISMATCH