BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 6562745 · Received May 12, 2017

    Report

    Report Number
    1627487-2017-02486
    Event Type
    Injury
    Date Received
    May 12, 2017
    Date of Event
    April 18, 2017
    Report Date
    May 12, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, NO ANALYSIS WILL BE DONE AS THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. 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. REFERENCE MFT REPORT #1627487-2017-02503. NOTE: IT IS UNKNOWN WHICH LEAD HAS THE ISSUE; THEREFORE BOTH LEADS ARE BEING REPORTED. IT WAS REPORTED ONE OF THE LEADS MIGRATED. THE LEAD WAS EXPLANTED AND REPLACED. THE STIMULATION WAS TESTED INTRA-OP AND THE PATIENT REPORTEDLY RECEIVED EFFECTIVE STIMULATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344698 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 69359

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other MODEL 1192, SCS ANCHOR| MODEL 3662, SCS IPG