BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3193646 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-05905
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 EXPERIENCES A BURNING SENSATION AND NUMBNESS IN HER FEET WHEN STIMULATION IS ON. THE SYMPTOMS SUBSIDE WHEN THE LEVEL OF STIMULATION IS REDUCED. ALLEGEDLY, THE PATIENT'S DOCTOR FEELS THE BURNING SENSATION OCCURS DUE TO THE PATIENT'S PAIN BEING NEUROPATHIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289322 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3422935

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other SCS IPG: MODEL 3788| IMPLANT: