BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2872823 · Received December 13, 2012

    Report

    Report Number
    3007566237-2012-03009
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    THE DEEPEST CONTACT ON THE ELECTRODE IN THE VIM WAS BELOW THE THALAMUS AND BELIEVED TO BE TOO LATERAL TO BE OF VALUE. IT WAS ALSO REPORTED IN THE SAMPLE POPULATION THA TNONE OF THE ELECTRODES WERE CONSIDERED TO BE MISPLACED, BASED ON INTRAOPERATIVE STIMULATION AND POSTOPERATIVE IMAGING.

    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 DISEASE PROGRESSION AND GRADUAL LOSS OF THERAPEUTIC EFFECT. THE ELECTRODE WAS REPLACED AT AGE (B)(6). UPON REPLACEMENT, IT WAS FOUND THAT A FIBROUS SHEET HAD FORMED OVER THE DISTAL ELECTRODES. THE NEW ELECTRODE WAS PLACED IN THE CAUDAL ZONA INCERTA (CZI). HAND FUNCTION AND TREMOR IMPROVED WHEN EVALUATED TWO YEARS LATER.

    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 00064 YR Required Intervention