BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3961140 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-03468
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    August 28, 2007
    Report Date
    June 23, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 2 OF 2. REFERENCE MFR. REPORT: 1627487-2014-03467. THE PATIENT REPORTED SHE HAS NOT RECEIVED EFFECTIVE STIMULATION SINCE ONE YEAR AFTER IMPLANT. THE PATIENT ALSO REPORTED SHE HAS NOT USED/CHARGED HER SCS SYSTEM IN AT LEAST 2 YEARS DUE TO UNRELATED HEALTH AND PERSONAL ISSUES. THE PATIENT NO LONGER HAS HER EXTERNAL DEVICES AND IS WITHOUT STIMULATION. THE SYSTEM IS TO BE EVALUATED AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413194 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION SYSTEMS 3186 55542

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other