BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3950197 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-23344
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    March 18, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION. X-RAYS WERE TAKEN AND REVEALED POSSIBLE LEAD MIGRATION. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SUBSEQUENTLY, THE PT UNDERWENT SURGICAL INTERVENTION WHERE THE LEAD WAS REMOVED AND REPLACED WITH A NEW ONE. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376666 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION SYSTEMS 3219 4240105

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: