BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3141820 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-12735
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    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

    IT WAS REPORTED THE PT'S TRIAL ENDED EARLY DUE TO LACK OF RELIEF FROM THE STIMULATION. THE PT ALSO EXPERIENCED WEAKNESS IN HIS LEGS AFTER THE LEADS WERE REMOVED, BUT THE DOCTOR WAS NOT CONCERNED. FOLLOW-UP REVEALED THE PT'S WEAKNESS IS GETTING WORSE. THE PHYSICIAN DOES NOT KNOW IF THIS IS DUE TO THE TRIAL OR THE PT'S MEDICAL CONDITION. THE PT WAS REFERRED TO A NEUROLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233530 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 3994287

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention