BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 110542 · Received July 8, 1997

    Report

    Report Number
    110542
    Event Type
    Injury
    Date Received
    July 8, 1997
    Date of Event
    February 6, 1997
    Report Date
    February 19, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    S/P PACEMAKER IMPLANTATION INSERTION IN 1992. 6 MONTH HX OF INTERMITTENT DIZZINESS, DECREASED EXERCISE TOLERANCE AND DYSPNEA WITH PALPITATIONS. IN 1995 HAD REPLACEMENT OF VENTRICULAR LEAD. EKG DEMONSTRATED AT TIME OF H & P INADEQUATE ATRIAL SENSING. ADD'L COMPLAINTS AT TIME OF H & P WERE OCCASIONAL PAIN IN LEFT ARM. MEASUREMENT AT TIME OF OPERATION CONFIRMED INSULATION FAILURE.. ATRIAL LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant ATRIAL LEAD FOR PACING HEART DTB MEDTRONIC, INC. 4504 M *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R