BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3925789 · Received June 17, 2014

    Report

    Report Number
    1627487-2014-15468
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    April 4, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 IS EXPERIENCING INEFFECTIVE STIMULATION. REPROGRAMMING WAS UNABLE TO PROVIDE EFFECTIVE COVERAGE. X-RAYS ARE TO BE TAKEN AND THE PT IS TO CONSULT WITH HER PHYSICIAN REGARDING UNDERGOING POSSIBLE SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356796 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4287034

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other IMPLANTED:| IMPLANTED| SCS ANCHOR: MODEL 1194| IMPLANTED:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192