BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3850325 · Received May 30, 2014

    Report

    Report Number
    1627487-2014-23359
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2012
    Report Date
    May 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 THE PT NO LONGER EXPERIENCED PAIN. SUBSEQUENTLY, SHE TURNED HER SCS SYSTEM OFF AND HAD NOT USED IT IN APPROXIMATELY 2 YEARS. RECENTLY, THE PT'S PAIN RESURFACED, BUT SHE WAS UNABLE TO TURN HER SYSTEM BACK ON. THE PT IS TO CONSULT WITH THE SJM REPRESENTATIVE TO HAVE HER SCS SYSTEM INTERROGATED. ADDITIONALLY, THE PT MAY UNDERGO SURGICAL INTERVENTION AT A FUTURE DATE AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319980 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 2832726

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other MODEL: 3186 (2)| IMPLANT DATE: