BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR FOR DBS

    MDR report key: 5664536 · Received May 18, 2016

    Report

    Report Number
    3007566237-2016-02038
    Event Type
    Injury
    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

    DATE OF EVENT: 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. THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. 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

    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 THE (B)(6) FEMALE DYSTONIA PATIENT (PATIENT 2) HAD A 14-YEAR HISTORY OF GENERALIZED DYSTONIA INVOLVING MAINLY THE LEGS AND TO A LESSER DEGREE THE UPPER LIMBS. SHE WAS UNABLE TO WALK WITHOUT CANES. BECAUSE THERAPEUTIC TRIALS INCLUDING TRIHEXYPHENIDYL, TETRABENAZINE, BACLOFEN, AND LEVODOPA CAUSED NO MEANINGFUL IMPROVEMENT, THEY WERE STOPPED LONG BEFORE THE OPERATION. ON EXAMINATION, INCREASED MUSCULAR TENSION OF THE LOWER EXTREMITIES AND ALSO OF THE UPPER LIMBS WAS PRESENT, CAUSING SEVERE SUPINATION OF THE FOOT WITH PERSISTENT DIFFICULTY WHEN STANDING AND WALKING UNAIDED OR WITH CANES. IN AN EFFORT TO TREAT THE DYT 1 GENERALIZED DYSTONIA PATIENT'S SYMPTOMS, SHE WAS IMPLANTED WITH BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) ELECTRODES. HOWEVER, "DURING A TESTING PERIOD WITH PERCUTANEOUS LEAD EXTENSIONS, THE INFECTION OF THE PERCUTANEOUS EXTENSIONS AND SUBSEQUENT MENINGITIS MADE THE REMOVAL OF THE ELECTRODES AND THERAPY WITH SYSTEMIC ANTIBIOTICS NECESSARY." IT WAS FURTHER REPORTED THE "INFECTION OF THE EXTERNAL PERCUTANEOUS ELECTRODES AND OF THE IMPLANTED MATERIAL" OCCURRED DURING THE TIME OF THE TEMPORARILY EXTERNAL CONNECTION OF ELECTRODES. "MICROBIOLOGY TESTS PROVED KLEBSIELLA PNEUMONIA TO BE RESPONSIBLE FOR THE INFECTION." ADDITIONALLY IT WAS REPORTED THE PATIENT'S LEADS WERE ACCIDENTALLY POSITIONED TO A MUCH MORE LATERAL POSITION (LOCALIZATION AT THE PUTAMEN/GPI BORDER) WHICH REDUCED THE CLINICAL BENEFIT OF DBS. THE PATIENT EXPERIENCED "EXCELLENT IMPROVEMENT OF THE RIGHT FOOT BUT LESS OF THE LEFT FOOT" PRIOR TO THE EXPLANT OF THEIR TRIAL SYSTEM. IT WAS NOTED THAT "A SECOND SUCCESSFUL IMPLANTATION WAS PERFORMED 2 MONTHS LATER FOLLOWING ANTIBACTERIAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318106 EXTERNAL NEUROSTIMULATOR FOR DBS IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention