BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3982709 · Received July 24, 2014

    Report

    Report Number
    1627487-2014-05520
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    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 3. REFERENCE MFR. REPORT#: 1627487-2014-05521. REFERENCE MFR. REPORT#: 1627487-2014-05522. IT WAS REPORTED THE PATIENT LOST STIMULATION AFTER SHE TWISTED TO STRETCH HER BACK. AN IMPEDANCE CHECK REVEALED LOW IMPEDANCE. REPROGRAMMING RESTORED ONLY MINIMAL STIMULATION, BUT STIMULATION LOSS OCCURRED WHEN THE PATIENT BENT OR TWISTED HER BODY. X-RAYS WERE TAKEN AND NO ANOMALIES WERE FOUND. THE NEXT COURSE OF ACTION WILL BE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434862 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3062371

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR