BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE EXTENSION

    MDR report key: 3161737 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-10187
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT (B)(6) WAS TO RECEIVE A LEAD EXTENSION AT THE CONCLUSION OF THE SCS TRIAL. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE LEAD INTO THE EXTENSION HEADER. IT WAS NOTED THAT THE PHYSICIAN TURNED THE SCREW ONE HALF TURN AND THE SCREW FELL OUT. THE PHYSICIAN THEN REPLACED THE LEAD EXTENSION WITHOUT ISSUE. THIS EVENT EXTENDED THE PROCEDURE BY APPROX 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248724 SINGLE EXTENSION SCS LEAD EXTENSION LGW ST JUDE MEDICAL - NEUROMODULATION 3383 3901136

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention