BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3232831 · Received July 18, 2013

    Report

    Report Number
    3007566237-2013-02392
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    March 17, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (B)(4).

    Description of Event or Problem · 1

    OYAMA, G., FOOTE, K., D., HWYNN, N., JACOBSON IV, C. E., MALATY, I. A., RODRIGUEZ, R. L., ZEILMAN, P., OKUN, M. S. RESCUE LEADS: A SALVAGE TECHNIQUE FOR SELECTED PATIENTS WITH A SUBOPTIMAL RESPONSE TO STANDARD DBS THERAPY. PARKINSONISM AND RELATED DISORDERS. 2011;17(6):451-455. DOI: 10.1016/J.PARKRELDIS.2011.03.009. SUMMARY: WE PRESENT FOUR CASES WHERE SUPPLEMENTARY ¿RESCUE¿ DEEP BRAIN STIMULATION (DBS) LEADS WERE ADDED FOR PATIENTS WHO FAILED TO OBTAIN ANTICIPATED CLINICAL BENEFITS. NINE PATIENTS OUT OF 295 PATIENTS WHO UNDERWENT DBS BETWEEN 2002 AND 2009, WERE IDENTIFIED AS RESCUE LEAD RECIPIENTS. OF THESE NINE CASES, FOUR CASES WERE EVALUATED. TWO HAD MEDICATION REFRACTORY TREMOR WHICH WAS INCOMPLETELY SUPPRESSED BY VIM (NUCLEUS VENTRALIS INTERMEDIUS) THALAMIC DBS, AND SUPPLEMENTAL RESCUE LEADS WERE IMPLANTED IN EITHER THE VO (VENTRAL ORALIS) THALAMIC NUCLEUS OR THE STN (SUBTHALAMIC NUCLEUS). THE REMAINING TWO CASES WERE PATIENTS WITH SEVERE DYSTONIA WHO WERE INITIALLY TREATED WITH BILATERAL GPI (GLOBUS PALLIDUS INTERNUS)-DBS, AND FOLLOWING SUBOPTIMAL CLINICAL BENEFITS, A SECOND GPI RESCUE LEAD WAS ADDED IN A CASE, AND BILATERAL STN RESCUE LEADS WERE ADDED IN THE OTHER CASE. OUTCOMES OF SCORES COLLECTED INCLUDED FAHN-TOLOSA-MARIN TREMOR RATING SCALE (TRS) FOR TREMOR CASES AND THE UNIFIED DYSTONIA RATING SCALE (UDRS) FOR DYSTONIA CASES AND THE SYMPTOM SPECIFIC PATIENT GLOBAL IMPRESSION SCALES (PGIS; 7 POINT SCALE). IN THE TREMOR CASES, THE TRS SCALE IMPROVED BY 34.1 _ 7.4% AND THE PGIS FOLLOWING RESCUE LEAD WAS ¿MINIMALLY IMPROVED¿ TO ¿VERY MUCH IMPROVED¿ (RANGE 1E2). IN DYSTONIA CASES, THE UDRS IMPROVED BY 50.0 _ 23.6% AND THE PGIS WAS ¿MINIMALLY IMPROVED¿ TO ¿VERY MUCH IMPROVED¿(RANGE 1E2) AFTER RESCUE LEAD SURGERY. THIS SMALL RETROSPECTIVE CASE SERIES DEMONSTRATED THAT, IN APPROPRIATELY SELECTED PATIENTS WITH SUBOPTIMAL RESULTS OF STANDARD DBS THERAPY, THE ADDITION OF RESCUE LEAD(S) MAY PROVIDE MEANINGFUL CLINICAL BENEFIT. REPORTED EVENT: (B)(6) MAN HAD LEAD REVISED. 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
    335080 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention