BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS LEAD

    MDR report key: 1026892 · Received April 8, 2008

    Report

    Report Number
    MW5006147
    Event Type
    Injury
    Date Received
    April 8, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH A MEDTRONIC ICD IN 2007, SPRINT FIDELIS LEAD LFJ MODEL # 694965. THE DEVICE FIRED WHILE I WAS AT REST. VERY DISTRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD NONE LWS MEDTRONIC 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Disability