BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2821144 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-02576
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 3, 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-02577. THE PT REC'D TWO PERCUTANEOUS LEADS AS PART OF HER SCS SYSTEM FOR BILATERAL LOW BACK AND LEG PAIN. IT WAS REPORTED, THE PT WENT TO THE EMERGENCY ROOM DUE TO PAIN IN THE TOP LEFT SIDE OF HER BACK. SHE STATED, SHE DEVELOPED THE PAIN SEVERAL DAYS AFTER THE IMPLANT AND IT HAD BEEN GETTING WORSE. A CT SCAN WAS PERFORMED AND SHOWED NO ANOMALIES. THE NEUROSURGEON STATED, THE PAIN WAS MOST LIKELY UNRELATED TO THE SCS SYSTEM AND SURGERY. THE PT REC'D A CORTISONE INJECTION TO ALLEVIATE THE PAIN. F/U IDENTIFIED THE PT FELT ONLY MILD DISCOMFORT. REPROGRAMMING EFFORTS PROVIDED EFFECTIVE STIMULATION COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3637214

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: