BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3891888 · Received June 10, 2014

    Report

    Report Number
    1627487-2014-21380
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 20, 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 INFO RELATED TO THE PT'S MED 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 MED HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A FALL AND HAS FELT PAIN IN HIS MID-BACK AREA IN ADDITION TO A CHANGE IN STIMULATION. REPROGRAMMING WAS UNSUCCESSFUL AS EFFECTIVE LEFT SIDE STIMULATION COULD NOT BE RESTORED. THE PT WAS GIVEN INJECTIONS AND X-RAYS WILL BE TAKEN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341175 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3377950

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788