BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3900112 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-15409
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 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 INFO RELATED TO THE PT'S MED 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 UNDERWENT A PROCEDURE FOR A TRIAL SCS SYSTEM. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE EPIDUCER NEEDLE AFTER PLACING 2 LEADS (FROM THE SAME LOT), THE PT EXPERIENCED PAIN. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEADS AND THEN ELECTED TO ABANDON THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315160 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 4414113

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other