BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3083297 · Received April 29, 2013

    Report

    Report Number
    3007566237-2013-01468
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    February 13, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. : PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ORTEGA-CUBERO, S., CLAVERO, P., IRURZUN, C., GONZALEZ-REDONDO, R., GURIDI, J., OBESO, J. A., RODRIGUEZ-OROZ, M. C. EFFECT OF DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS ON NON-MOTOR FLUCTUATIONS IN PARKINSON'S DISEASE: TWO-YEAR' FOLLOW-UP. PARKINSONISM <(>&<)> RELATED DISORDERS. 2013;19(5):543-547. DOI: 10.1016/J.PARKRELDIS.2013.02.001. SUMMARY: DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN-DBS) REDUCES MOTOR FLUCTUATIONS IN PARKINSON'S DISEASE (PD) BUT ITS EFFECT ON NON-MOTOR FLUCTUATIONS (NMF) IS NOT WELL KNOWN. IN THIS STUDY WE ASSESS THE EFFICACY OF STN-DBS ON NMF TWO YEARS AFTER SURGERY. AUTONOMIC, COGNITIVE, PSYCHIATRIC AND SENSORY NMF IN 20 PATIENTS WERE EVALUATED USING A QUESTIONNAIRE DESIGNED TO ASSESS THE FREQUENCY AND SEVERITY OF THE NMF PREOPERATIVELY AND AFTER TWO YEARS OF FOLLOW-UP. THE UPDRS SCALE WAS USED FOR ASSESSING THE MOTOR STATE. COMPARED WITH THE PREOPERATIVE SITUATION, STN-DBS AT 2 YEARS OF FOLLOW-UP WAS ASSOCIATED WITH A SIGNIFICANT REDUCTION IN THE NUMBER AND SEVERITY OF AUTONOMIC AND PSYCHIATRIC NMF IN THE "OFF" STATE (WITHOUT MEDICATION), AND IN THE SEVERITY OF SENSORY NMF, WHICH WERE NOT OBSERVED IN THE "ON" STATE (WITH MEDICATION). A CROSS-SECTIONAL ANALYSIS AT THE TWO-YEAR TIME-POINT OF THE FOUR POSSIBLE MOTOR CONDITIONS (COMBINING MEDICATION AND STIMULATION) SHOWED A REDUCTION IN THE TOTAL NUMBER OF NMF AND IN THE SEVERITY OF AUTONOMIC AND SENSORY NMF AFTER SWITCHING ON THE STIMULATION IN THE "ON" STATE. IMPROVEMENT OF THE UPDRS-MOTOR SCORE WAS CORRELATED WITH A REDUCTION IN THE SEVERITY BUT NOT IN THE FREQUENCY OF NMF. A WORSENING OF MOTOR FUNCTION AFTER SUPPRESSING STIMULATION IN THE "OFF" STATE WAS NOT PARALLELED BY A WORSENING OF NMF. AFTER TWO YEARS OF FOLLOW-UP, STN-DBS IN THE "OFF" MEDICATION WAS ASSOCIATED WITH A REDUCTION IN THE FREQUENCY AND SEVERITY OF NMF. THESE RESULTS WILL NEED TO BE CONFIRMED IN CONTROLLED STUDIES. REPORTED EVENTS: 1 PATIENT EXPERIENCED INCORRECT PLACEMENT OF ONE ELECTRODE THAT REQUIRED FURTHER SURGERY 4 MONTHS LATER. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184502 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention