BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 1571296 · Received January 4, 2010

    Report

    Report Number
    MW5014197
    Event Type
    Malfunction
    Date Received
    January 4, 2010
    Date of Event
    December 30, 2009
    Report Date
    December 30, 2009
    Manufacturer
    CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STYLET TORE THROUGH PACER WIRE DURING REPOSITIONING. READING REPLACEMENT - GOOD OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL STYLET KAT DWS CARDIAC RHYTHM MANAGEMENT DIVISION 4091 9423911

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR