BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 811140 · Received January 23, 2007

    Report

    Report Number
    811140
    Event Type
    Injury
    Date Received
    January 23, 2007
    Date of Event
    October 12, 2006
    Report Date
    January 22, 2007
    Manufacturer
    METRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED FOR AICD CHANGE DUE TO A REPORTED INAPPROPRIATE SHOCK, OVERSENSING OF NOISE AND SUSPECTED LEAD FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC AICD LWS METRONIC, INC. 6949 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention