BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6069269 · Received November 1, 2016

    Report

    Report Number
    3007566237-2016-03836
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    August 24, 2016
    Report Date
    December 13, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    O'HALLORAN, R.L., CHARTRAIN, A.G., RASOULI, J., RAMDHANI, R.A., KOPELL, B.H. A CASE STUDY OF IMAGE-GUIDED DEEP BRAIN STIMULATION: MRI-BASED WHITE MATTER TRACTOGRAPHY SHOWS DIFFERENCES IN RESPONDERS AND NON-RESPONDERS. WORLD NEUROSURGERY. 2016. 1878. SEP 1. DOI: 10.1016/J.WNEU.2016.08.103 SUMMARY: THE CAUDAL ZONA INCERTA (CZI) IS AN INCREASINGLY POPULAR DEEP BRAIN STIMULATION (DBS) TARGET FOR THE TREATMENT OF TREMOR-PREDOMINANT DISEASE. THE DENTATORUBROTHALAMIC TRACT (DRTT) IS A WHITE MATTER FIBER BUNDLE THAT TRAVERSES THE CZI AND CAN BE IDENTIFIED USING DIFFUSION WEIGHTED MAGNETIC RESONANCE IMAGING FIBER TRACTOGRAPHY (DMRI-FT) TO ASCERTAIN ITS PRECISE COURSE. IN THIS REPORT, WE COMPARE TWO PATIENT CASES OF CZI DBS, A RESPONDER AND A NONRESPONDER. REPORTED EVENT: PATIENT 2: A (B)(6) MAN WITH DEEP BRAIN STIMULATION (DBS) FOR TREMOR-DOMINANT PARKINSON'S DISEASE (PD) INITIALLY EXPERIENCED >90% REDUCTION IN BASELINE TREMOR BUT THEY DEVELOPED BREAKTHROUGH TREMOR OF THE LEFT HEMIBODY SEVERAL MONTHS AFTER SURGERY. HE ALSO EXPERIENCED EPISODIC, DISABLING DYSTONIA OF HIS LEFT LOWER EXTREMITY AND SIGNIFICANT SLURRING OF HIS SPEECH. DESPITE CLOSE FOLLOW-UP AND MAXIMAL ADJUSTMENT OF THE DBS DEVICE SETTINGS, HE CONTINUED TO EXPERIENCE THESE SYMPTOMS. AT SIX-MONTHS POST-IMPLANT STIMULATION INDUCED SYMPTOMS WERE SEEN IN THE LEFT LOWER EXTREMITY THAT ADVERSELY AFFECTED HIS GAIT. DBS SETTINGS WERE: LEFT: 3-2-C+, 3.2V, 60MSEC, 145HZ. RIGHT (INTERLEAVED): 3-C-, 2.8/2.5V, 120/90 MSEC, 80/80 HZ. THE AUTHORS REPORTED THAT SUBSEQUENT IMAGING SHOWED THE RIGHT-SIDED DBS LEAD WAS SLIGHTLY POSTERIOR TO THE IDEAL TARGET LOCATION, BUT STILL SITUATED WELL WITHIN THE CAUDAL ZONA INSERTA (CZI). THE RIGHT LEAD WAS REVISED AND REPLACED WITH A NEW LEAD WITH A MORE ANTERIOR TARGET CLOSER TO THE SUBTHALAMIC NUCLEUS, RESULTING IN SIGNIFICANT IMPROVEMENT IN HIS LEFT-SIDED DYSTONIC SYMPTOMS AND TREMOR. THE AUTHORS NOTED THAT DIFFUSION TENSOR IMAGING SUGGESTED THAT THIS PATIENT HAD AN ATYPICAL DENTATORUBROTHALAMIC TRACT, WHICH THEY HYPOTHESIZED WAS AN EXPLANATION FOR THE PATIENTIMPROVED RESPONSE AFTER LEAD REVISION. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3389.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR CONFIRMED THAT THE LEAD PLACEMENT ISSUE WAS NOT RELATED TO ANY HARDWARE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722350 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention