BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3999905 · Received August 11, 2014

    Report

    Report Number
    3007566237-2014-02245
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    April 4, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DATE REFLECTS THE DATE THAT THE ARTICLE WAS PUBLISHED ONLINE. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    MARRAS, C.F., RIZZI, M., CANTONETTI, L., REBESSI, E., DE BENEDICTIS, A., PORTALURI, F., RANDI, F., SAVIOLI, A., CASTELLI, E., VIGEVANO, F. PALLIDOTOMY FOR MEDICALLY REFRACTORY STATUS DYSTONICUS IN CHILDHOOD. DEVELOPMENTAL MEDICINE <(>&<)> CHILD NEUROLOGY. 2014; 56(649-656) SUMMARY: STATUS DYSTONICUS IS A RARE AND POTENTIALLY FATAL CONDITION OF CONTINUOUS AND GENERALIZED MUSCLE CONTRACTION THAT CAN COMPLICATE DYSTONIA. AS STATUS DYSTONICUS IS USUALLY REFRACTORY TO TRADITIONAL PHARMACOLOGICAL THERAPY, ALTERNATIVE AND INVASIVE STRATEGIES HAVE BEEN DEVELOPED, BUT SO FAR THERE ARE NO GUIDELINES ON STATUS DYSTONICUS MANAGEMENT. PALLIDOTOMY HAS SHOWN GOOD RESULTS IN STATUS DYSTONICUS TREATMENT. WE REPORT INDICATIONS, SURGICAL STRATEGY, AND OUTCOME OF BILATERAL PALLIDOTOMY IN FOUR PEDIATRIC PATIENTS (FOUR MALES; MEAN AGE AT SURGERY 11Y 5MO) WITH SECONDARY DYSTONIA, WHO DEVELOPED REFRACTORY STATUS DYSTONICUS. PALLIDOTOMY WAS PERFORMED IN THE AREA CORRESPONDING TO THE MID PORTION OF THE GLOBUS PALLIDUS INTERNUS. THIS PROCEDURE ALLOWED PATIENTS TO RECOVER THE PRE-STATUS DYSTONICUS CONDITION, CONTROLLING DYSTONIC POSTURES AND MOVEMENTS OF TRUNK AND LIMBS. MOREOVER OROMANDIBULAR DYSTONIA, WHICH IS RESISTANT TO CONSERVATIVE APPROACHES AND DEEP BRAIN STIMULATION, WAS SIGNIFICANTLY REDUCED. NO POSTOPERATIVE COMPLICATIONS WERE REGISTERED. OUR STUDY SUGGESTS PALLIDOTOMY AS A FEASIBLE TREATMENT IN PATIENTS WITH SECONDARY DYSTONIA COMPLICATED BY STATUS DYSTONICUS. REPORTED EVENT: AT THE AGE OF 10 YEARS, WITHOUT ANY APPARENT PROVOKING FACTOR, HE HAD A STATUS DYSTONICUS RELAPSE WITH CLINICAL FEATURES SIMILAR TO THE FIRST EPISODE. A NOVEL ITB PUMP IMPLANTATION WAS PERFORMED, BUT IT WAS REMOVED SOON AFTER BECAUSE THE HARDWARE BECAME INFECTED. A TRACHEOSTOMY WAS THEN PERFORMED AND SEVERAL DRUGS WERE ADMINISTRATED WITHOUT EFFICACY. THE PATIENT DEVELOPED SEPSIS AND DEEP VEIN THROMBOSIS, AND 2 MONTHS FROM STATUS DYSTONICUS ONSET, A BILATERAL PALLIDOTOMY WAS PERFORMED. SEE LITERATURE ARTICLE ATTACHED TO MANUFACTURER REPORT #3007566237-2014-02244.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476285 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR Required Intervention