BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3954918 · Received July 16, 2014

    Report

    Report Number
    1627487-2014-20045
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    January 21, 2013
    Report Date
    June 25, 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 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 EXPERIENCED SORENESS, DISCOMFORT, AND A BUMP AT THE LEAD SITE. IT WAS ALSO REPORTED THE PT IS EXPERIENCING INEFFECTIVE STIMULATION. THE PT IS TO CONSULT WITH HER PHYSICIAN AND TRY REPROGRAMMING WITH THE SJM REP AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416314 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3860321

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other SCS IPG, MODEL 3788| IMPLANT DATE: