BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3649230 · Received December 3, 2013

    Report

    Report Number
    1627487-2013-11786
    Event Type
    Injury
    Date Received
    December 3, 2013
    Date of Event
    August 30, 2013
    Report Date
    November 7, 2013
    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 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 PATIENT HASN'T RECEIVED ADEQUATE COVERAGE SINCE BEING IMPLANTED. IN TURN, THE PATIENT WAS GIVEN NEW PROGRAMS VIA AN SJM REP. THE PATIENT AGREED TO TRY THE NEW PROGRAM AND LATER DECIDE THE NEXT STEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626232 PENTA GZB ST. JUDE MEDICAL- NEUROMODULATION 3228 4116634

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other IMPLANT:| SCS IPG: MODEL 3788