BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2442413 · Received February 8, 2012

    Report

    Report Number
    3007566237-2012-00269
    Event Type
    Injury
    Date Received
    February 8, 2012
    Date of Event
    June 1, 2009
    Report Date
    January 12, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: D: UNK EXPLANTED: UNK. THE EXACT EVENT DATE WAS NOT PROVIDED. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: MICHA SOBSTYL1, MIROS AW Z BEK1, SEBASTIAN DZIERZÊCKI1, ZBIGNIEW MOSSAKOWSKI2, KRZYSZTOF SZCZA UBA3. SUCCESSFUL BILATERAL PALLIDAL STIMULATION IN A PATIENT WITH ISOLATED LOWER LIMB DYSTONIA COEXISTENT WITH LANGERHANS CELL HISTIOCYTOSIS AND COELIAC DISEASE. NEUROLOGIA I NEUROCHIRURGIA POLSKA 2011; 45, 5: 514-519. SUMMARY: THE AUTHORS REPORT A CASE OF BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) STIMULATION FOR TREATMENT OF MEDICALLY INTRACTABLE I SOLATED LOWER LIMB DYSTONIA. THE (B)(6) GIRL DEVELOPED DYSTONIC MOVEMENTS IN HER LEFT LOWER LIMB. AT THE AGE OF (B)(6), THE PATIENT WAS HANDICAPPED BY DYSTONIC MOVEMENTS IN HER LOWER LIMBS, AND BECAME WHEELCHAIR-BOUND. PHARMACOLOGICAL THERAPY AND BOTULINUM TOXIN INJECTION RESULTED IN TRANSIENT AND MODEST BENEFIT. MOREOVER, THE PATIENT WAS DIAGNOSED WITH HISTOLOGICALLY PROVEN COELIAC DISEASE AND LANGERHANS CELL HISTIOCYTOSIS. GENETIC TESTING REVEALED THE PRESENCE OF DYT-1 MUTATION. THE (B)(6) GIRL UNDERWENT BILATERAL IMPLANTATION OF DEEP BRAIN STIMULATION LEADS. BILATERAL GPI STIMULATION RESULTED IN REMARKABLE IMPROVEMENT OF PHASIC DYSTONIC MOVEMENTS, AND DYSTONIC POSTURE OF LOWER LIMBS. OVER 2 YEARS POSTOPERATIVE FOLLOW-UP, THE PATIENT IS ABLE TO WALK INDEPENDENTLY. BILATERAL GPI STIMULATION APPEARS TO BE AN EFFECTIVE TREATMENT MODALITY FOR ISOLATED LOWER LIMB DYSTONIA. REPORTED EVENT: FIVE MONTHS AFTER IMPLANT, THE PATIENT EXPERIENCED A SUDDEN RECURRENCE OF DYSTONIA IN HER RIGHT FOOT. THE SLIPPED CONNECTOR CAUSED BREAKAGE OF THE DBS LEAD NEAR THE BURR HOLE. THE BROKEN LEFT LEAD WAS REPLACED STEREOTACTICALLY UNDER GENERAL ANESTHESIA. POST-OPERATIVE CT AND MRI SHOWED PROPER PLACEMENT OF THE NEW LEFT DBS LEAD. THE PATIENT REGAINED BENEFIT. AFTER 24 MONTHS OF CONTINUOUS BILATERAL GPI STIMULATION, THE PATIENT EXPERIENCED A 72% REDUCTION IN FUNCTIONAL AND A 80% REDUCTION IN MOTOR SCORES OF THE BURKE-FAHN-MARSDEN DYSTONIA RATING (BFMDR) SCALE. THERE WAS STILL OCCASIONAL RIGHT FOOT INVERSION WITH CURLING OF THE RIGHT BIG TOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3387 LOT# UNK SERIAL# UNKNOWN IMPLANTE