BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3940446 · Received June 18, 2014

    Report

    Report Number
    1627487-2014-20001
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 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

    THE COMPLAINT FOR "LEAD MIGRATION" WAS CONFIRMED BASED ON EVENT DETAILS "THE PATIENT'S RIGHT OCTRODE HAD MIGRATED DOWN FROM T8 TO T11-T12 CONFIRMED VIA X-RAY. PATIENT WAS GETTING SOME EFFECTIVE THERAPY BUT HAD LOST SOME BACK COVERAGE. IT IS UNK IF THE PATIENT HAD ANY FALLS OR TRAUMA BEFORE THE CHANGE IN STIMULATION. 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. REFER TO MFR REPORT 1627487-2014-20002. IT WAS REPORTED THAT THE PATIENT WAS RECEIVING INEFFECTIVE COVERAGE. X-RAYS CONFIRMED ONE OF THE SCS LEADS HAD MIGRATED. AS A RESULT, LEADS WERE EXPLANTED AND REPLACED WHICH RESOLVED THE ISSUE. IT WAS ALSO REPORTED THAT THE SCS IPG WAS ELECTIVELY EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357752 OCTRODE SCS LEAD GZB ST JUDE MEDICAL NEUROMODULATION 3186 173790

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other IMPLANT DATE:| SCS IPG: MODEL 3716,