BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3890722 · Received June 3, 2014

    Report

    Report Number
    1627487-2014-05409
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    December 1, 2009
    Report Date
    May 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 INFO 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT #: 1627487-2014-05410. IT WAS REPORTED THE PT STOPPED USING HIS SCS SYSTEM DUE TO STIMULATION BEING NON-BENEFICIAL SINCE IMPLANTED. IN TURN, THE PT HAS BEEN RECEIVING STIMULATION IN UNINTENDED AREAS. AS SJM REPRESENTATIVE STATED OTHERWISE, ESPECIALLY AFTER EACH TIME THE PT WAS REPROGRAMMED PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324392 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3173 2757221

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other IMPLANTED:| SCS IPG: MODEL: 3788