BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2926025 · Received January 17, 2013

    Report

    Report Number
    1627487-2013-05098
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    DEVICE 2 OF 2. REF MFR REPORT #1627487-2013-05097. ON (B)(4) 2012, THE PT UNDERWENT A TRIAL PROCEDURE. DURING THE PROCEDURE, THE PT EXPERIENCED CEREBROSPINAL FLUID LEAKAGE. A FEW DAYS AFTER THE PROCEDURE, THE PT EXPERIENCED KIDNEY STIMULATION AND NUMBNESS IN HER LEGS. AS A RESULT, BOTH LEADS WERE REMOVED. THE PT WAS GIVEN ANTIBIOTICS AND WILL PURSUE OTHER TREATMENT OPTIONS. THE DOCTOR FEELS THE PT IS NOT A CANDIDATE FOR AN SCS SYSTEM DUE TO PSYCHOLOGICAL REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25589 UNK SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention