BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 5664585 · Received May 18, 2016

    Report

    Report Number
    3007566237-2016-02040
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    December 18, 2001
    Report Date
    May 18, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. SECTION OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3387, LOT# UNKNOWN, 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

    BEREZNAI, B., STEUDE, U., SEELOS, K., BOTZEL, K. CHRONIC HIGH-FREQUENCY GLOBUS PALLIDUS INTERNUS STIMULATION IN DIFFERENT TYPES OF DYSTONIA: A CLINICAL, VIDEO, AND MRI REPORT OF SIX PATIENTS PRESENTING WITH SEGMENTAL, CERVICAL, AND GENERALIZED DYSTONIA. MOVEMENT DISORDERS. 2002. 17:1 (138-144). DOI 10.1002/MDS.1250. SUMMARY: THE RESULTS OF DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) IN SIX PATIENTS WITH GENERALIZED, FOCAL, AND SEGMENTAL DYSTONIA ARE PRESENTED. REPORTED EVENTS: IT WAS REPORTED THAT A (B)(6) FEMALE DYT 1 GENERALIZED DYSTONIA PATIENT (PATIENT 2) WHO'S SEVERE IN-TURNING OF THE FOOT COMPLETELY DISAPPEARED ON THE RIGHT SIDE AND MARKEDLY IMPROVED ON THE LEFT SIDE" EXPERIENCED A CHANGE IN EFFECT FOLLOWING THE REPLACEMENT OF THEIR DEEP BRAIN STIMULATION (DBS) TRIAL SYSTEMS. IT WAS STATED THAT "AFTER THE SECOND OPERATION, THE PATIENT'S LEFT FOOT WAS ASYMPTOMATIC BUT THE RIGHT FOOT SHOWED DYSTONIC PLANTAR FLEXION AFTER WALKING 20 METERS." T WAS NOTED "THESE DIFFERENT CLINICAL RESULTS CORRELATED WITH DIFFERENT ELECTRODE POSITIONS" AND THAT "DURING THE SECOND IMPLANTATION BOTH ELECTRODE POSITIONS WERE ACCIDENTALLY MORE TO THE LEFT BY APPROXIMATELY 3 MM." THE "ACCIDENTAL POSITIONING OF THE ELECTRODES TO A MUCH MORE LATERAL POSITION (LOCALIZATION AT THE PUTAMEN/GPI BORDER) REDUCED THE CLINICAL BENEFIT OF THE DBS" AND "CAUSED THE IMPROVEMENT TO SWITCH TO THE OTHER SIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319589 ITREL II IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 7424 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR