BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3537857 · Received December 26, 2013

    Report

    Report Number
    3007566237-2013-04165
    Event Type
    Injury
    Date Received
    December 26, 2013
    Date of Event
    November 5, 2013
    Report Date
    December 4, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387 LOT# UNKNOWN, (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    MIQUEL, M., SPAMPINATO, U., LATXAGUE, C., AVILES-OLMOS, I., BADER, B., BERTRAM, K., BHATIAM K., BURBAUD,M P., BURGHAUS, L., WHAN CHO, J., CUNY, ,E., FOLTYNIE, T., GARCIA RUIZ, P . J., GIMENEZ-ROLDAN, S., GUEHL, D., GURIDI, J., HARIZ, M., JARMAN, P., KEFALOPOULOU, Z. M., LIMOUSIN, P., LIPSMAN, N., LOZANO, A. M., MORO, E., NGY, D., RODRIGUEZ-OROZ, M. C., SHANG, H., SHIN, H., WALKER, R. H., YOKOCHI, F., ZRINZO, L., TISON, F. SHORT AND LONG TERM OUTCOME OF BILATERAL PALLIDAL STIMULATION IN CHOREA-ACANTHOCYTOSIS. PLOS ONE. 2013;8(11):E79241. SUMMARY: CHOREA-ACANTHOCYTOSIS (CHAC) IS A NEUROACANTHOCYTOSIS SYNDROME PRESENTING WITH SEVERE MOVEMENT DISORDERS POORLY RESPONSIVE TO DRUG THERAPY. CASE REPORTS SUGGEST THAT BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE VENTRO-POSTERO-LATERAL INTERNAL GLOBUS PALLIDUS (GPI) MAY BENEFIT THESE PATIENTS. TO EXPLORE THIS ISSUE, THE PRESENT MULTICENTRE (N=12) RETROSPECTIVE STUDY COLLECTED THE SHORT AND LONG TERM OUTCOME OF 15 PATIENTS WHO UNDERWENT DBS. DATA WERE COLLECTED IN A STANDARDIZED WAY 2-6 MONTHS PREOPERATIVELY, 1-5 MONTHS (EARLY) AND 6 MONTHS OR MORE (LATE) AFTER SURGERY AT THE LAST FOLLOW-UP VISIT (MEAN FOLLOW-UP: 29.5 MONTHS). MOTOR SEVERITY, ASSESSED BY THE UNIFIED HUNTINGTON¿S DISEASE RATING SCALE-MOTOR SCORE, UHDRS-MS), WAS SIGNIFICANTLY REDUCED AT BOTH EARLY AND LATE POST-SURGERY TIME POINTS (MEAN IMPROVEMENT 54.3% AND 44.1%, RESPECTIVELY). FUNCTIONAL CAPACITY (UHDRS-FUNCTIONAL CAPACITY SCORE) WAS ALSO SIGNIFICANTLY IMPROVED AT BOTH POSTSURGERY TIME POINTS (MEAN 75.5% AND 73.3%, RESPECTIVELY), WHEREAS INCAPACITY (UHDRS-INDEPENDENCE SCORE) IMPROVEMENT REACHED SIGNIFICANCE AT EARLY POST-SURGERY ONLY (MEAN 37.3%). LONG TERM SIGNIFICANT IMPROVEMENT OF MOTOR SYMPTOM SEVERITY (=20 % FROM BASELINE) WAS OBSERVED IN 61.5 % OF THE PATIENTS. CHOREA AND DYSTONIA IMPROVED, WHEREAS EFFECTS ON DYSARTHR IA AND SWALLOWING WERE VARIABLE. PARKINSONISM DID NOT IMPROVE. LINEAR REGRESSION ANALYSIS SHOWED THAT PREOPERATIVE MOTOR SEVERITY PREDICTED MOTOR IMPROVEMENT AT BOTH POST-SURGERY TIME POINTS. THE MOST SERIOUS ADVERSE EVENT WAS DEVICE INFECTION AND CEREBRAL ABSCESS, AND ONE PATIENT DIED SUDDENLY OF UNCLEAR CAUSE, 4 YEARS AFTER SURGERY. THIS STUDY SHOWS THAT BILATERAL DBS OF THE GPI EFFECTIVELY REDUCES THE SEVERITY OF DRUG-RESISTANT HYPERKINETIC MOVEMENT DISORDERS SUCH AS PRESENT IN CHAC. REPORTED EVENT: A (B)(6) FEMALE PATIENT EXPERIENCED ¿TWIDDLER SYNDROME¿ WITH LEAD RUPTURE THAT REQUIRED THE REPLACEMENT OF THE ENTIRE DEVICE SYSTEM FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675655 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention