BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICD LEAD 1581

    MDR report key: 642057 · Received September 20, 2005

    Report

    Report Number
    642057
    Event Type
    Malfunction
    Date Received
    September 20, 2005
    Date of Event
    July 25, 2005
    Report Date
    September 20, 2005
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CAME TO OUR LAB FOR LEAD REPLACEMENT SINCE IT WAS IMPOSSIBLE TO REPOSITION IT. THE PHYSICIAN WAS UNABLE TO GET THE SCREW BACK, SO THE LEAD WAS EXTRACTED. THE LEAD WAS ORIGINALLY PLACED ON 06/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICD LEAD 1581 ICD LEAD LWS ST. JUDE MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR