BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4092201 · Received September 3, 2014

    Report

    Report Number
    1627487-2014-26689
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    March 25, 2014
    Report Date
    August 12, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    DEVICE #1 OF 2: REFERENCE MFR REPORT: 1627487-2014-26690. THE PT REPORTS SHE IS NOT RECEIVING STIMULATION IN HER RIGHT LEG DESPITE TROUBLESHOOTING. THE SJM REPRESENTATIVE MET WITH THE PT AND CONFIRMED THE ISSUE. AN X-RAY WAS TAKEN AND REVEALED THE LEADS HAVE MIGRATED. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535360 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3583486

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: