BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3810758 · Received April 28, 2014

    Report

    Report Number
    1627487-2014-23282
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 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 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 IS EXPERIENCING OVERSTIMULATION. IT WAS ALSO REPORTED THE OVERSTIMULATION REMAINS PRESENT WHEN THE PT ADJUSTS THE AMPLITUDE TO LOW. IN ADDITION, THE PT MAY HAVE AN MRI PERFORMED. SUBSEQUENTLY, THE PT WILL UNDERGO SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253939 PENTA SCS LEAD GZB ST. JUDE MEDICAL: NEUROMODULATION 3228 3794703

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other IMPLANT DATE:| SCS EXTENSION: MODEL 3386 (2)| SCS IPG: MODEL 3788| IMPLANT DATE