BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3926321 · Received June 17, 2014

    Report

    Report Number
    1627487-2014-12409
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 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 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

    IT WAS REPORTED THE PT'S STIMULATION CHANGED WHEN HE MOVED POSITIONS. THE PT ALSO REPORTED THE STIMULATION WAS INEFFECTIVE FOR PAIN CONTROL. THE PHYSICIAN EXPLANTED THE ENTIRE SCS SYSTEM. THE PT RECEIVED TWO LEADS FROM THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355928 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3108757

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHORS: MODEL 1194 (2)