BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3161464 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-15761
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 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

    THE PATIENT UNDERWENT A PROCEDURE TO RECEIVE A PERMANENT SCS SYSTEM ON (B)(6) 2013. IT WAS REPORTED A DURAL TEAR OCCURRED WHICH RESULTED IN A CEREBROSPINAL FLUID LEAK DURING THE PROCEDURE. THE PATIENT COMPLAINED OF A HEADACHE POSTOPERATIVELY. FOLLOW-UP INDICATED THE PATIENT HAS SOME POSITIONAL HEADACHES, BUT THEY ARE SUBSIDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248930 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3885824

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192| IMPLANT DATE: