BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170872 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10041
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT OUT OF RANGE PACING IMPEDANCES WERE ONCE AGAIN REVEALED AT A FOLLOW UP AND A LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PACING IMPEDANCES HAD BEEPING RISING ON THIS RIGHT VENTRICULAR LEAD, AND SOME IMPEDANCES HAD BEEN OUT OF RANGE. ALL OTHER MEASUREMENTS APPEARED NORMAL. SOME NOISE WAS REPRODUCED AND THE PATIENT COMPLAINED FEELING TWITCHES, BUT NO EPISODES WERE NOTED. TECHNICAL SERVICES DISCUSSED A POSSIBLE CONNECTION ISSUE, SET SCREW ISSUE OR A INSULATION ISSUE. AT THIS TIME THIS DEVICE AND LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention 0158| E110| 1871| 4076