BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3192074 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-13939
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 24, 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
    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

    DEVICE 3 OF 3. REFERENCE MFR. REPORT: 1627487-2013-13937 AND 1627487-2013-13938. IT WAS REPORTED THE PATIENT HAD STATED HER STIMULATION HAD CHANGED APPROXIMATELY A WEEK AGO. X-RAYS REVEALED THE TOP HEADER PORT LEAD WAS SLIGHTLY PULLED OUT OF THE IPG. A SJM REPRESENTATIVE WAS ABLE TO REPROGRAM THE PATIENT USING THE EXISTING BOTTOM PORT LEAD. THE PATIENT WAS TO HAVE A CT/MYELOGRAM SCAN AND FOLLOW-UP WITH HER PHYSICIAN. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281094 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3290702

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL 1192| SCS ANCHOR, MODEL 1192