BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEON MINI

    MDR report key: 3961814 · Received June 25, 2014

    Report

    Report Number
    1627487-2014-26589
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    November 22, 2013
    Report Date
    June 5, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 INFO 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. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PT REPORTS THAT APPROXIMATELY 6 MONTHS AGO (EXACT DATE UNK) SHE BEGAN EXPERIENCING PAINFUL HEATING AND SWELLING FROM THE LOW BACK TO THE IPG WHEN THE STIMULATION WAS TURNED ON. THE PT DECLINED REPROGRAMMING AND REQUESTS THE SCS SYSTEM TO BE REMOVED AS SHE DOES NOT REQUIRE THE USE OF HER SCS SYSTEM. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370567 MEON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 393443

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other SCS LEAD: MODEL 3228| IMPLANTED: