BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3223324 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-08322
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 7, 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
    AZ, 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 HAD PARTICIPATED IN PHYSICAL THERAPY AND SINCE THAT TIME, HE HAD DIMINISHED STIMULATION. IT WAS REPORTED THE PATIENT INITIALLY HAD THAT STIMULATION COVERED FOR THE BILATERAL LEGS BUT AFTER THE PHYSICAL THERAPY, THE PATIENT HAD ONLY THE LEFT SIDED COVERAGE. THE PATIENT ALSO REPORTED A FEW PROGRAMS HURT HIM. FOLLOW-UP INFORMATION RECEIVED THE SJM REPRESENTATIVE REPROGRAMMED THE DEVICE BUT WAS ABLE TO PROVIDE STIMULATION ONLY ON ONE SIDE. X-RAY IMAGERY REVEALED THE LEAD WAS INTACT BUT HAD MOVED DOWN A LEVEL. REPROGRAMMING WAS DONE AGAIN AND THE PATIENT WAS TO HAVE A FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316058 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3175686

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788