BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110792 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02634
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    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: 1627487-2013-02635 AND 1627487-2013-02636. IT WAS REPORTED, THE PATIENT FELT INEFFECTIVE STIMULATION COVERAGE AS SHE ONLY FELT STIMULATION ON HER RIGHT SIDE. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCES ON MULTIPLE LEAD CONTACTS. X-RAYS SHOWED NO LEAD ANOMALIES, AND THE PATIENT DENIED ANY FALLS OR TRAUMATIC EVENTS. IT WAS REPORTED, THE PATIENT IS TRYING TO DECIDE WHETHER SHE WANTS A REVISION PROCEDURE. AS THE AFFECTED DEVICES ARE UNKNOWN, ALL POSSIBLE LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204721 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3444720

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (3)| SCS EXTENSION, MODEL 3341| SCS IPG, MODEL 3788