BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4202467 · Received October 21, 2014

    Report

    Report Number
    1627487-2014-01664
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATIION
    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 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

    IT WAS REPORTED THE PT EXPERIENCED UNCOMFORTABLE STIMULATION. SUBSEQUENTLY, THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE STIMULATION WAS ACHIEVED POSTOPERATIVELY. REPORTEDLY, THE PHYSICIAN ELECTIVELY REPLACED THE IPG DURING THE SAME PROCEDURE. THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669596 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATIION 3186 4358121

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788