BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3223018 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-04865
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION, AND THE LEAD APPEARED TO HAVE MIGRATED DOWNWARD AND TO ONE SIDE. IT WAS REPORTED THE PHYSICIAN PLANNED TO UNDERTAKE SURGICAL INTERVENTION TO ADDRESS THE ISSUE AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317675 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3583268

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other SCS IPG: MODEL 3716| IMPLANT: