BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST JUDE MEDICAL

    MDR report key: 838094 · Received April 11, 2007

    Report

    Report Number
    MW1042565
    Event Type
    Other
    Date Received
    April 11, 2007
    Date of Event
    March 21, 2007
    Report Date
    March 30, 2007
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ST JUDE LEAD TENDRIL WAS IMPLANTED AND THEN REMOVED/REPLACED DUE TO A PROBLEM WITH THE SCREW (WOULD NOT SCREW IN). NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL TENDRIL DEFIB LEAD SET LWS ST JUDE MEDICAL 1788TC *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other