BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

    MDR report key: 5647900 · Received May 11, 2016

    Report

    Report Number
    3007566237-2016-01936
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    January 1, 2016
    Report Date
    May 11, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE YEAR OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ROWE, J., KHAN, A., ROMANOWSKI, C., ISAAC, C., KHAN, S., MAIR, R., AZIZ, T., YIANNI, J. CLINICAL EXPERIENCE WITH PEDUNCULOPONTINE NUCLEUS STIMULATION IN CONDITIONS WITH NIGRO-STRIATAL DISCONNECTION. WORLD NEUROSURGERY.2015. 1878. 89:9-18. DEC 15:DOI: 10.1016/J.WNEU.2015.11.054 SUMMARY: THE PEDUNCULOPONTINE NUCLEUS (PPN) IS A PART OF THE MESENCEPHALIC LOCOMOTOR REGION AND, IN RECENT YEARS, IT HAS BEEN CONSIDERED A NEW SURGICAL TARGET FOR DEEP BRAIN STIMULATION (DBS) FOR MOVEMENT DISORDERS INCLUDING ATYPICAL PARKINSONIAN SYNDROMES SUCH AS PROGRESSIVE SUPRANUCLEAR PALSY (PSP) AND MULTIPLE SYSTEM ATROPHY. INVOLVEMENT OF THE PPN MAY PLAY AN IMPORTANT ROLE IN GAIT IMPAIRMENT IN THESE DISORDERS AND THE DEVELOPMENT OF PPN DBS COULD POTENTIALLY PROVIDE TREATMENT FOR THIS DISABLING PROBLEM. HOWEVER, THE ROLE OF THE PPN AND THE SPECIFIC PATHWAYS INVOLVED IN GAIT CONTROL AND OTHER MOTOR FUNCTIONS ARE POORLY UNDERSTOOD. REPORTED EVENT: PATIENT 1: A (B)(6) MALE PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE PEDUNCULOPONTINE NUCLEUS (PPN) TO TREAT GENERALIZED DYSTONIA EXPERIENCED A SIGNIFICANT CLINICAL IMPROVEMENT INITIALLY, BUT 4 YEARS AFTER IMPLANT THE PATIENT REPORTED DETERIORATION IN SYMPTOMS AND WAS FOUND TO HAVE A LEAD BREAKAGE. THE AUTHORS NOTED THAT THE LEAD WAS REVISED WITH "GOOD EFFECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300929 IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention