BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2831888 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-02636
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 15, 2012
    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 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

    THE PT REC'D A PERCUTANEOUS LEAD IN HER THORACIC REGION AS PART OF HER SCS SYSTEM. IT WAS REPORTED, THE PT FELT A CHANGE IN STIMULATION AFTER TAKING A WALK. SHE REPORTED STIMULATION IN HER TAILBONE AND LATER REPORTED STIMULATION IN HER CHEST AND UNDER HER LEFT ARM. THE PT STATED, SHE HAD A FLUOROSCOPY DONE WHICH REVEALED "SOMETHING HAD MOVED". REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AT RESOLVING THE ISSUE AND THE PT REPORTED, SHE NO LONGER FEELS EFFECTIVE STIMULATION COVERAGE. F/U IDENTIFIED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3700980

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192| IMPLANT:| IMPLANT: