BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3243666 · Received July 23, 2013

    Report

    Report Number
    3007566237-2013-02457
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    November 6, 2012
    Report Date
    July 16, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

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

    Description of Event or Problem · 1

    ZAHOS, P.A., SHWEIKEH, F. FRAMELESS DEEP BRAIN STIMULATION SURGERY: A COMMUNITY HOSPITAL EXPERIENCE. CLINICAL NEUROLOGY AND NEUROSURGERY. 2013;115(7):1083-1087. SUMMARY: FRAME-BASED STEREOTAXY HAS REGULARLY BEEN UTILIZED FOR DEEP BRAIN STIMULATION (DBS) SURGERY. MORE RECENTLY, FRAMELESS NEUROAVIGATION HAS REVEALED SIMILAR OUTCOMES FOR FUNCTIONAL NEUROSURGICAL OPERATIONS. SUCH COMPARABLE OUTCOMES HAVE BEEN DESCRIBED BY TERTIARY REFERRAL CENTERS, BUT WHETHER SUCH EXCELLENT SURGICAL OUTCOMES ARE ATTAINABLE IN A COMMUNITY SETTING HAS YET TO BE REPORTED. EIGHTEEN PATIENTS RECEIVED FRAMELESS DBS SURGERY, 11 WITH SUBTHALAMIC NUCLEUS (STN) IMPLANTATION FOR PARKINSON¿S DISEASE (PD) AND 7 WITH VENTRAL INTERMEDIATE NUCLEUS (VIM) IMPLANTATION FOR ESSENTIAL TREMOR (ET). THEIR DATA WAS COLLECTED AND ANALYZED, INCLUDING THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS) AND TREMOR SCORES. THERE WAS A 58% REDUCTION IN UPDRS III AND A 47% REDUCTION IN OVERALL LEVODOPA DOSE IN THOSE WITH STN DBS (P <(><<)> 0.0001 AND P <(><<)> 0.0005, RESPECTIVELY) AND THOSE WITH VIM DBS HAD A 76% IMPROVEMENT IN THEIR OVERALL TREMOR RATING SCORE (P <(><<)> 0.002) AT MEAN FOLLOW-UP (8.2 AND 10.1 MONTHS, RESPECTIVELY). NO INTRAOPERATIVE COMPLICATIONS OCCURRED. TWO SUBJECTS DEVELOPED WOUND DEHISCENCE POST-OPERATIVELY AND ANOTHER HAD FALL-INDUCED LEAD FRACTURE, ALL TREATED WITH UNCOMPLICATED HARDWARE REPLACEMENT. FRAMELESS DBS FOR PD AND ET CAN BE SAFELY PERFORMED IN A COMMUNITY SETTING WITH SIMILAR EXCELLENT OUTCOMES AS THOSE OF LARGER ACADEMIC CENTERS AS WELL AS CLINICAL RESULTS COMPARABLE TO FRAME BASED SURGERY. PATIENTS LIVING IN COMMUNITY OR RURAL AREAS MAY NOT NEED TO TRAVEL ACROSS CITY OR EVEN STATE LINES TO RECEIVE THIS SURGICAL OPTION, ESPECIALLY IF THEY HAVE THE OPPORTUNITY TO RECEIVE IT CLOSER TO HOME. REPORTED EVENTS: 2 PATIENTS DEVELOPED WOUND DEHISCENCE POST-OPERATIVELY. ALL TREATED WITH UNCOMPLICATED HARDWARE REPLACEMENT. ONE PATIENT HAD FALL-INDUCED LEAD FRACTURE. PATIENT WAS TREATED WITH UNCOMPLICATED HARDWARE REPLACEMENT. 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
    343302 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention