BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110645 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-13738
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-13737. THE PATIENT HAS TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED, THE PATIENT'S STIMULATION WOULD TURN ON AND OFF WITHOUT PROMPTING AND WAS AS THE PATIENT DESCRIBED GIVING HER "SHOCKS". THE PATIENT DESCRIBED IT AS SHOOTING PAIN GOING DOWN HER LEGS AND ACROSS HER BACK WHICH WOULD LAST APPROXIMATELY 5 MINUTES. THE PATIENT STATED THIS HAS BEEN OCCURRING MORE OFTEN IN THE PAST 4-5 MONTHS. A SJM REPRESENTATIVE MET WITH THE PATIENT AND TURNED OFF THE MAGNET MODE. PATIENT TO KEEP RECORD OF WHEN THE SYSTEM TURNS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205590 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3088707

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)