BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3123602 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-03656
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 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 RECEIVED 2 TRAIL SCS SCS LEADS (OFF-LABEL) WITH THE SAME LOT NUMBER. IT WAS REPORTED DURING THE PT'S OCCIPITAL TRIAL (OFF-LABEL), THE PT INADVERTENTLY REMOVED HIS BANDAGE. SUBSEQUENTLY, THE LEFT SCS LEAD WAS PARTIALLY PULLED OUT OF THE SKIN AND THE PT WAS NO LONGER RECEIVING STIMULATION. A SJM REPRESENTATIVE WAS ABLE TO OBTAIN EFFECTIVE STIMULATION WITH REPROGRAMMING AND BANDAGES/STERI-STRIPS WERE APPLIED TO THE AREA. FOLLOW-UP IDENTIFIED THE PT COMPLETED THE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219312 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3905154

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention