BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1061872 · Received June 13, 2008

    Report

    Report Number
    MW5007343
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    MEDTRONIC, INC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ICD LEAD OVER SENSING, LOSS OF CAPSURE. RETURNED TO MEDTRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ICD LEAD LWS MEDTRONIC, INC 6949-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability