BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1593111 · Received January 28, 2010

    Report

    Report Number
    MW5014592
    Event Type
    Injury
    Date Received
    January 28, 2010
    Date of Event
    January 11, 2010
    Report Date
    January 28, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FRACTURE OF RT VENTRICULAR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEAD WITH ELEVATED PACING THRESHOLDS NOTED AS WELL AS INAPPROPRIATE NOISE DETECTION FROM THIS LEAD. TO AVOID INAPPROPRIATE SENSING, SHE HAS BEEN PROGRAMMED TO A DOO MODE, BUT HAS NOTED SOME EXERTIONAL INTOLERANCE, WITH A LACK OF RATE RESPONSE CAPABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC CARDIOVERTER-DEFIBRILLATOR LEAD NIK MEDTRONIC D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Disability