BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 988510 · Received January 23, 2008

    Report

    Report Number
    MW5005131
    Event Type
    Injury
    Date Received
    January 23, 2008
    Date of Event
    January 16, 2008
    Report Date
    January 23, 2008
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC PACE MAKER SPRINT FIDELES LEADS WERE SHOCKING PT REPEATEDLY, EMS HAD TO TAKE PT TO THE HOSP AND THE LEADS WERE REPLACED BY SURGERY 2008. DATES OF USE: 04/2007 - 01/2008. DIAGNOSIS OR REASON FOR USE: LEADS FOR PACE MAKER DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SPRINT FIDELIS LWS 6949-65C

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L