BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3950533 · Received July 10, 2014

    Report

    Report Number
    1627487-2014-12458
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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

    DEVICE 1 OF 2. REF MFR REPORT# 1627487-2014-12459. IT WAS REPORTED THE PT LOST STIMULATION COVERAGE. DIAGNOSTIC TESTING REVEALED MAY INVALID CONTACTS. AN SJM REP REPROGRAMMED THE RIGHT LEAD TO PROVIDE SOME STIMULATION ON THE RIGHT SIDE, HOWEVER, THE PT DOES NOT RECEIVE EFFECTIVE STIMULATION FOR HER PAIN. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD. THE PT REPORTED RECEIVING EFFECTIVE STIMULATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403870 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4132959

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other SCS ANCHORS, MODEL 1192 (2)| SCS IPG, MODEL 3716| IMPLANT DATE| IMPLANT DATE