BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3431211 · Received October 21, 2013

    Report

    Report Number
    1627487-2013-18517
    Event Type
    Injury
    Date Received
    October 21, 2013
    Date of Event
    September 27, 2013
    Report Date
    September 27, 2013
    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCES SEIZURES. THE SEIZURES OCCUR MOSTLY WHEN THE PT IS LAYING DOWN. THE PT USES HIS SCS SYSTEM CONTINUOUSLY AND WAS ADVISED TO TURN THE SYSTEM OFF. THE PT STATED HIS PHYSICIAN REFERRED TO THE SEIZURES AS PSEUDO SEIZURES AND REFERRED HIM TO A PSYCHIATRIST AS THE PHYSICIAN FEELS THEY MAY BE CAUSED BY STRESS. THE PT'S SPOUSE INDICATED AN EEG WAS PERFORMED AND THE SEIZURES WERE FOUND TO BE NON-EPILEPTIC IN NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537822 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3136517

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788