BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4253001 · Received November 12, 2014

    Report

    Report Number
    1627487-2014-05772
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ST. JUDE MED - 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 PATIENT HAS BEEN EXPERIENCING OVERSTIMULATION SINCE TWISTING HIS BACK. OVERSTIMULATION OCCURS WHEN STIMULATION IS ON AND WHEN HE'S IN CERTAIN POSITIONS. IT WAS ALSO REPORTED THE PATIENT IS UNABLE TO RECEIVE EFFECTIVE THERAPY DUE TO PROGRAMS AUTO-REDUCING. IN TURN, AN SJM REPRESENTATIVE REPROGRAMMED THE PATIENT AND HE WILL USE THE PROGRAMS IN THE MEANTIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729038 PENTA SCS LEAD GZB ST. JUDE MED - NEUROMODULATION 3228 3422900

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: