BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2872787 · Received December 13, 2012

    Report

    Report Number
    3007566237-2012-03007
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4). 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: WITHIN A COUPLE OF MONTHS OF IMPLANT THE EFFECT ON TREMOR WAS VIRTUALLY LOST.

    Description of Event or Problem · 1

    BLOMSTEDT, P., LINDVALL, P., LINDER, J., OLIVECRONA, M., FORSGREN, L., HARIZ, M. I. REOPERATION AFTER FAILED DEEP BRAIN STIMULATION FOR ESSENTIAL TREMOR. WORLD NEUROSURGERY. 2012;78(5):554.E551-555. DOI: 10.1016/J.WNEU.2011.12.013. SUMMARY: TO EVALUATE THE EFFECTS OF REOPERATION WITH DEEP BRAIN STIMULATION (DBS) IN THE CAUDAL ZONA INCERTA (CZI) IN PATIENTS WITH FAILED DBS IN THE VENTRAL INTERMEDIATE (VIM) NUCLEUS OF THE THALAMUS FOR ESSENTIAL TREMOR. THE RESULTS OF REOPERATION WITH CZI DBS IN FIVE PATIENTS WITH FAILED VIM DBS WERE RETROSPECTIVELY ANALYZED. TWO PATIENTS HAD EARLY FAILURE OF VIM DBS, AND THREE AFTER SEVERAL YEARS OF GOOD EFFECT. THE MEAN DEVIATION FROM THE ATLAS VIM TARGET POINT WAS 1.4 MM. BEFORE THE REOPERATION VIM DBS IMPROVED HAND FUNCTION AND TREMOR IN THE TREATED HAND AT 25 %, WHEREAS CZI DBS ACHIEVED AN IMPROVEMENT OF 57%. ALTHOUGH CZI WAS MORE EFFICIENT THAN VIM DBS, ALSO IN THE PATIENTS WITH LATE FAILURE OF VIM DBS, THEY STILL EXHIBITED A CONSIDERABLE RESIDUAL TREMOR ON CZI DBS. THE EFFECT ON TREMOR WAS, IN THIS SMALL SAMPLE POPULATION, IMPROVED BY IMPLANTING AN ELECTRODE IN THE CZI. THE EFFECT WAS MODEST IN THOSE PATIENTS SUFFERING DETERIORATION YEARS AFTER THE INITIAL OPERATION. REPORTED EVENT: A (B)(6) MALE EXPERIENCED STIMULATION-INDUCED HEADACHE AND SENSORY SIDE EFFECTS FOLLOWING IMPLANT. THE SYSTEM WAS REMOVED. PRODUCT ANALYSIS WAS PERFORMED BY THE MANUFACTURER AND FOUND NO DEVICE ISSUE. THE PATIENT WAS REIMPLANTED IN THE LEFT CAUDAL ZONA INCERTA (CZI) AND TREMOR AND HAND FUNCTION WERE IMPROVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention