BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3150046 · Received May 30, 2013

    Report

    Report Number
    1627487-2013-15711
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    THE PT HAS 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. THE PT REPORTED HE IS NO LONGER RECEIVING STIMULATION IN THE MIDDLE OF HIS BACK AND SHOULDER BLADES SUBSEQUENT TO SUFFERING A FALL. THE PT STATED HIS PHYSICIAN ORDERED X-RAYS AND THEY INDICATED ONE OF THE LEADS HAD MIGRATED. NO SURGICAL INTERVENTION HAS BEEN PLANNED TO BE UNDERTAKEN REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238014 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3757196

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS IPG: MODEL: 3788| IMPLANT DATE: