BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3954935 · Received July 16, 2014

    Report

    Report Number
    1627487-2014-20047
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    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 2 OF 2. REFERENCE MFR REPORT # 1627487-2014-20046. IT WAS REPORTED DURING THE TRIAL PROCEDURE, THE PT EXPERIENCED SEVERE PAIN AND ALSO EXPERIENCED BACK PAIN AND PRESSURE WHEN STIMULATION WAS TURNED ON. THE PT WAS GIVEN PAIN MEDICATION AND THE LEADS WERE REPOSITIONED DURING THE PROCEDURE. ALSO, POST-OPERATIVELY THE PT COMPLAINED OF UNCOMFORTABLE RIB AND CHEST STIMULATION WITH STIMULATION ON. AS A RESULT, THE LEADS WERE EXPLANTED. THE PT WAS TRANSFERRED TO THE ER AND THE PHYSICIAN ORDERED AN MRI. FOLLOW UP IDENTIFIED THE PT'S MRI WAS NORMAL AND THE PT WAS RELEASED FROM THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415889 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 4565475

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other