BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850273 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-26415
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-26416. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION AND UNDERWENT A SURGICAL PROCEDURE WHERE A NEW LEAD WAS IMPLANTED. THE PATIENT NOW HAS 3 LEADS THOUGH ONLY TWO ARE CONNECTED TO THE IPG. EFFECTIVE STIMULATION WAS RESTORED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290586 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 2867112

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other SCS IPG: MODEL 3788| IMPLANT: