BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3881877 · Received June 18, 2014

    Report

    Report Number
    3007566237-2014-01704
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    MENEES, S., HOELZER, B., MOESCHLER, S. FLUOROSCOPICALLY-GUIDED EPIDURAL FIBRIN GLUE BLOOD PATCH AS DEFINITIVE THERAPY FOR PERSISTENT CEREBROSPINAL FLUID LEAK: A CASE STUDY. REGIONAL ANESTHESIA AND PAIN MEDICINE. 2013;38(1). SUMMARY: A CASE OF DELAYED PERSISTENT CSF LEAKAGE FOLLOWING INTRATHECAL PUMP IMPLANTATION, SEROMA FORMATION, AND SUBSEQUENT DRAINAGE IS PRESENTED HERE. REPORTED EVENT: A SIXTY-TWO YEAR OLD MALE PRESENTED WITH PROGRESSIVE UPPER AND MORE PRONOUNCED LOWER EXTREMITY TREMORS SECONDARY TO AN UNKNOWN ETIOLOGY. HE UNDERWENT AN INTRATHECAL BACLOFEN TEST DOSE WITH SIGNIFICANT IMPROVEMENT IN HIS LOWER EXTREMITY SPASTICITY. TWO WEEKS FOLLOWING THE TEST DOSE, AN INTRATHECAL PUMP WITH BACLOFEN WAS PLACED WITHOUT COMPLICATION AND HIS SYMPTOMS IMPROVED GREATLY. ONE YEAR AFTER INTRATHECAL PUMP IMPLANTATION, THE PATIENT NOTED SWELLING AND PAIN OVER THE CATHETER SITE AS WELL AS A NEW ONSET POSITIONAL HEADACHE. THE PATIENT WAS EVALUATED AND UNDERWENT MAGNETIC RESONANCE IMAGING. A SEROMA WAS IDENTIFIED ADJACENT TO THE CATHETER AT THE RIGHT LUMBAR REGION. TWO WEEKS LATER, AN ULTRASOUND GUIDED ASPIRATION OF THE LUMBAR SEROMA WAS PERFORMED SHOWING CLEAR, SLIGHTLY YELLOW-TINGED FLUID THAT WAS CONFIRMED TO BE CSF. THE PATIENT UNDERWENT AN EPIDURAL BLOOD PATCH AND THIS IMPROVED HIS SYMPTOMS FOR SEVERAL DAYS AFTER WHICH TIME HIS SYMPTOMS RETURNED. TWO WEEKS LATER, HE UNDERWENT FLUOROSCOPICALLY GUIDED L2-3 INTERLAMINAR EPIDURAL FIBRIN GLUE BLOOD PATCH. TEN MILLILITERS OF FIBRIN GLUE ADDITIVE IN COMBINATION WITH TWO MILLILITERS OF AUTOLOGOUS BLOOD (TOTAL VOLUME OF TWELVE MILLILITERS) WAS ADMINISTERED TO THE POINT THAT THE PATIENT HAD A MILD PRESSURE PARESTHESIA. THE PATIENT HAS HAD COMPLETE RESOLUTION OF THE CSF LEAK FOLLOWING THE PROCEDURE. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357496 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention