BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040830 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02410
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 LEAD HAD AN ISSUE SIX MONTHS AGO THAT CAUSED THE DEVICE CAUSED THE DEVICE TO EMIT BEEP TONES. A LEAD REVISION PROCEDURE WAS PERFORMED. LEAD EXPLANT WAS NOT ABLE TO BE PERFORMED AND TACHY THERAPY WAS TURNED OFF ON THE COMPETITOR DEVICE. THREE TO FOUR DAYS AFTER THE REVISION AN INFECTION OCCURRED. THE PATIENT WAS GIVEN AN INFUSION OF ANTIBIOTICS FOR OVER 16 DAYS. IT WAS REPORTED THAT THE INFECTION DID NOT COMPLETELY CLEAR. THE PATIENT ADVOCATE NOTED CHANGING BANDAGES UNTIL THE DAY THE PATIENT EXPIRED (SIX MONTHS LATER). THE PATIENT WAS NOTED TO HAVE PASSED AWAY DUE TO PNEUMONIA. THE PATIENT ADVOCATE NOTED THE PATIENT SURVIVED 10 YEARS LONGER THAN ANYONE THOUGHT AS THE PATIENT WAS POST-MI WITH AN EJECTION FRACTION OF 13 PERCENT PRIOR TO THE DEVICE IMPLANT. IT WAS REPORTED THAT THE PATIENT WAS NOT HEALTHY/STRONG ENOUGH TO HAVE A NEW SYSTEM IMPLANTED ON THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143442 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R A135| 4479| MISMATCH| 0157