BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3022449 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-12374
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 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 LOST THE ABILITY TO WALK AND FELL. THE LOSS OF MUSCLE CONTROL WAS TEMPORARY. A CT SCAN WAS NEGATIVE FOR ANY TYPE OF NEUROLOGICAL DEFICIT DISORDERS. THE PATIENT HAS RECOVERED AND HAS NOT EXPERIENCED ANOTHER FALL. PROGRAMMING PROVIDED EFFECTIVE STIMULATION COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119709 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3880623

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788