BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3250218 · Received July 26, 2013

    Report

    Report Number
    3007566237-2013-02492
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    August 30, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    URGOSIK, D., JECH, R., RUZICKA, E. DEEP BRAIN STIMULATION IN PATIENTS SUFFERING FROM MOVEMENT DISORDERS - STEREOTACTIC PROCEDURE AND INTRAOPERATIVE FINDINGS. CESKA A SLOVENSKA NEUROLOGIE A NEUROCHIRURGIE. 2011;74(2):175-186. SUMMARY: INTRODUCTION: DEEP BRAIN STIMULATION (DBS) IS THE METHOD OF CHOICE IN THE TREATMENT OF VARIOUS MOVEMENT DISORDERS. METHODS: BETWEEN 1998 AND 2009, WE PERFORMED DBS IN 100 PATIENTS (F : M = 37 : 63; MEDIAN 56 YRS /12¿73 YRS/). FOURTEEN PATIENTS SUFFERED FROM ESSENTIAL TREMOR (ET), 2 FROM TREMOR OF OTHER AETIOLOGY (T), 73 FROM PARKINSON'S DISEASE (PD), 10 FROM GENERALIZED (GD) AND 1 FROM CERVICAL (CD) DYSTONIA. IMPLANTATION WAS TARGETED IN THE VENTRAL INTERMEDIAL THALAMUS (VIM) FOR ET, T AND PD, SUBTHALAMIC NUCLEUS (STN) FOR PD AND INTERNAL PALLIDUM (GPI) FOR GD, CD AND PD. INTRACEREBRAL ELECTRODES WERE TOTALLY IMPLANTED INTO 187 NUCLEI. WE EVALUATED STIMULATION PARAMETERS, WHILEC LINICAL RESPONSE AND PARAMETERS DETERMINED THE ACCURACY OF IMPLANTATION. RESULTS: THE LOWEST EFFECTIVE AMPLITUDE OF STIMULATION RANGED FROM 0.3 TO 2.5 V (MEDIAN 1 V). THE THERAPEUTIC INTERVAL RANGED FROM 0 TO 5 V (MEDIAN 2.5 V). TREMOR WAS ELIMINATED IN 92.9% OFCASES, RIGIDITY IN 94.7% AND AKINESIA IN 18.9%. THE CENTRAL TRAJECTORY WAS USED FOR FINAL ELECTRODE IMPLANTATION IN 56.7% OF PROCEDURES. IN STN THE TRAJECTORY PASSED THROUGH THE NUCLEUS IN THE RANGE OF 3.5-7.5 MM (MEDIAN 5 MM). THE DIFFERENCE OF COORDINATES BETWEEN EXPECTED AND REAL POSITION OF ELECTRODES WAS: X = 0.5 (0-1.5), Y = 0.7 (0-1.7), Z = 0.5 (0-1.7). THE MOST FREQUENT SIDE EFFECTS WERE PARAESTHESIAS (VIM 38%) AND DYSARTHRIA (STN 28.3%). OVERALL MORBIDITY OCCURRED IN 21% OF PATIENTS. CONCLUSION: THE RESULTS SHOWED ACCURATE TARGETING AND OPTIMAL IMPLANTATION TECHNIQUE WITH MINIMAL MORBIDITY. REPORTED EVENT: 1. 1 PATIENT HAD INFECTION SECONDARY TO DECUBITI IN THE AREA OF THE BATTERY AND CABLE. THE BATTERY AND CABLE WERE EXPLANTED, AND BATTERY WAS REIMPLANTED. 2. AN UNKNOWN NUMBER OF VIM PATIENTS HAD CONTRALATERAL ATAXIA OF UPPER LIMB FOLLOWING TEST STIMULATION. C50672 (FDP) 3. AN UNKNOWN NUMBER OF VIM PATIENTS HAD VEGETATIVE SYMPTOMS FOLLOWING TEST STIMULATION. C64343 (FDP) 4. AN UNKNOWN NUMBER OF VIM PATIENTS HAD CONTRALATERAL PARESIS OF UPPER LIMB FOLLOWING TEST STIMULATION. C50688 (FDP) 5. AN UNKNOWN NUMBER OF STN PATIENTS HAD OTHER VEGETATIVE MANIFESTATIONS FOLLOWING TEST STIMULATION. 6. AN UNKNOWN NUMBER OF STN PATIENTS HAD ATAXIA FOLLOWING TEST STIMULATION. 7. AN UNKNOWN NUMBER OF STN PATIENTS HAD PARESIS OF CONTRALATERAL EXTREMITY FOLLOWING TEST STIMULATION. 8. 1 PATIENT HAD LEAD POSITIONED INCORRECTLY.REIMPLANTATION WAS NOT REQUIRED. C63043 (FDD) 54, 77, 92 9. 1 PATIENT HAD LEAD POSITIONED INCORRECTLY. REIMPLANTATION WAS REQUIRED. POSITION WAS CORRECTED AND DEVICE WAS REIMPLANTED CORRECTLY. 10. 1 PATIENT HAD GENERALIZED PAROXYSM AS A PEROPERATIVE COMPLICATION. 11. 1 PATIENT HAD TRANSIENT HEMIPARESIS WITH A CORRELATE ON CT OF BRAIN EXTENSIVE FRONTAL PNEUMOCEPHALUS. 12. 4 PATIENTS HAD AMENTIVE STATE APPEAR WITH CONFUSION AND MOTOR RESTLESSNESS. 13. 1 PATIENT HAD AMENTIVE STATE APPEAR WITH CONFUSION AND MOTOR RESTLESSNESS WITH EXCESS SALIVATION WITH ASPIRATION AND SUBSEQUENT INTERRUPTION OF THE INTERVENTION. 14. 1 PATIENT HAD DAMAGE OF DURA MATER ADJACENT PART OF CORTEX AND SUBSEQUENT HEMORRHAGE FROM SMALL CORTICAL BLOOD VESSELS OCCURRED WHEN MAKING THE TREPANNING DRILL HOLE. AFTER STOPPING THE BLEEDING, SURGERY WAS CARRIED ON. NO PERMANENT NEUROLOGICAL MORBIDITY AS A RESULT. 15. 1 PATIENT HAD CABLE WINDING UPON ROTATION OF A LOOSE NEUROSTIMULATOR IN THE SUBDERMAL POCKET. 16. 1 PATIENT HAD DAMAGE TO CABLE BY EXTERNAL INJURY. 17. 1 PATIENT HAD AN INFECTION. THE BATTERY AND CABLE WERE EXPLANTED. 18. 1 PATIENT HAD DECUBITI IN THE AREA OF THE CABLE. THE BATTERY AND CABLE WERE EXPLANTED. 19. 1 PATIENT HAD INTOLERANCE OF THE BATTERY. THE BATTERY AND CABLE WERE EXPLANTED, AND THE BATTERY WAS REIMPLANTED. 20. 1 PATIENT HAD INFECTION SECONDARY TO CUT INTO SCALP. THE BATTERY AND CABLE WERE EXPLANTED, AND BATTERY AND CABLE WERE REIMPLANTED. 21. 1 PATIENT HAD DECUBITI IN THE AREA OF THE BATTERY. THE BATTERY WAS EXPLANTED, AND BATTERY WAS REIMPLANTED. 22. 1 PATIENT A GENERALIZED EPILEPTIC SEIZURE. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349989 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention