BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3932037 · Received June 20, 2014

    Report

    Report Number
    1627487-2014-05452
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    February 25, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAS BEEN RECEIVING INADEQUATE PAIN RELIEF DUE TO UNCOMFORTABLE/INEFFECTIVE STIMULATION. THE PT HAS ALSO BEEN RECEIVING STIMULATION IN AN UNINTENDED AREA THAT IS TOO INTENSE. FOLLOW-UP REVEALED THE PT HAS BEEN RECEIVING INADEQUATE COVERAGE SINCE BEING IMPLANTED. PRIOR REPROGRAMMING TO PROVIDE RESOLUTION WAS UNSUCCESSFUL. THE PT WAS RECENTLY GIVEN NEW PROGRAMS AND WILL TRY THEM OUT MOVING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362441 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 4294651

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other IMPLANT:| SCS IPG: MODEL 3788