BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4135655 · Received October 2, 2014

    Report

    Report Number
    3007566237-2014-02818
    Event Type
    Injury
    Date Received
    October 2, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED 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. CONCOMITANT PRODUCTS: 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; PRODUCT ID NEU_UNKNOWN_EXT, LOT # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    CHEUNG, T., FLATOW, V., BEN-HAIM, S., OSBORN, I., CHO, C., TAGLIATI, M., ALTERMAN, R. STATUS DYSTONICUS FOLLOWING DEEP BRAIN STIMULATION SURGERY IN DYT1 DYSTONIA PATIENTS. NEUROLOGY. 78 (1001): P01.227 DOI: 10.1212/WNL.78.1_MEETINGABSTRACTS.P01.227 SUMMARY: WE DESCRIBE A CASE SERIES OF PATIENTS WHO EXPERIENCED STATUS DYSTONICUS (SD), ALSO KNOWN AS DYSTONIC STORM, FOLLOWING DEEP BRAIN STIMULATION (DBS) SURGERY TO IMPLANT OR REMOVE ELECTRODES IN THE GLOBUS PALLIDUS PARS INTERNA (GPI). REPORTED EVENTS: 2 PATIENTS HAD AN EPISODE OF STATUS DYSTONICUS FOLLOWING DEEP BRIAN STIMULATOR (DBS) IMPLANTATION. THE CAUSE WAS PRESUMED TO BE SUDDEN CESSATION OF STIMULATION. IT WAS NOTED THAT THE DURATION OF THESE EPISODES RANGED FROM 3 TO 29 DAYS IN THE INTENSIVE CARE UNIT (ICU) WITH A SIMILAR DURATION OF CONTINUOUS INTRAVENOUS SEDATION REQUIREMENTS. ALL PATIENTS REPORTEDLY RECOVERED TO THEIR BASELINE DYSTONIA SEVERITY. THREE PATIENTS HAD AN EPISODE OF STATUS DYSTONICUS FOLLOWING DEEP BRIAN STIMULATOR (DBS) IMPLANTATION. THE CAUSE WAS PRESUMED TO BE SURGICAL STRESS FROM THE DBS LEAD IMPLANTATION. IT WAS NOTED THAT THE DURATION OF THESE EPISODES RANGED FROM 3 TO 29 DAYS IN THE INTENSIVE CARE UNIT (ICU) WITH A SIMILAR DURATION OF CONTINUOUS INTRAVENOUS SEDATION REQUIREMENTS. ALL PATIENTS REPORTEDLY RECOVERED TO THEIR BASELINE DYSTONIA SEVERITY. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. 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
    614938 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L