BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2844359 · Received November 16, 2012

    Report

    Report Number
    1627487-2012-11697
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 PATIENT WAS PROVIDED WITH A TRIAL LEAD. ON THE PROCEDURE TABLE THE LEAD WAS TESTED AND WAS PROVIDING STIMULATION RELIEF TO THE PAIN AREA. POSTOPERATIVE, THE PATIENT WAS NO LONGER RECEIVING STIMULATION IN THE CORRECT AREA. THE PHYSICIAN HAD AN X-RAY TAKEN WHICH REVEALED THE LEAD HAD MIGRATED. THE PHYSICIAN PLACED A NEW LEAD THE SAME DAY, AND IT WAS REPORTED STIMULATION COVERAGE WAS REGAINED DURING THE TRIAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention