BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3110667 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-05659
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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 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

    ON (B)(6) 2013, THE PT UNDERWENT A SURGICAL PROCEDURE TO RECEIVE A LEAD. POST-OP, THE PT EXPERIENCED NUMBNESS IN BOTH LEGS AND WAS UNABLE TO MOVE THEM. AS A RESULT, THE PT WAS TAKEN BACK INTO THE OPERATING ROOM. AN EPIDURAL HEMATOMA WAS FOUND AND THE LEAD WAS EXPLANTED. THE EPIDURAL HEMATOMA WAS TREATED AND THE PT REGAINED SENSATION/MOVEMENT IN BOTH LEGS. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207809 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3754666

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention