BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3133420 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-06312
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 DURING THE TRIAL PERIOD THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. THE PHYSICIAN REVIEWED THE ER REPORT AND HE STATED THE PATIENT HAD TAKEN MORE THAN THE PRESCRIBED AMOUNT OF MEDICATION, RESULTING IN INCOHERENCE. THE PATIENT HAS FULLY RECOVERED AND IS GOING FORWARD WITH THE PERMANENT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222975 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3876606

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention