BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 11112184 · Received January 4, 2021

    Report

    Report Number
    2182207-2021-00005
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    October 15, 2020
    Report Date
    January 4, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN. AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ALAIN KAELIN-LANG ET AL. BILATERAL PALLIDAL STIMULATION IMPROVES CERVICAL DYSTONIA FOR MORE THAN A DECADE. ELSEVIER: PARKINSONISM AND RELATED DISORDERS 81 (2020) 78¿81. DOI: 10.1016/J.PARKRELDIS.2020.10.028. TO INVESTIGATE THE IMPACT OF PALLIDAL DBS BEYOND 10 YEARS IN CD THE INVESTIGATORS FOLLOWED A SERIES OF FIVE CONSECUTIVE PATIENTS WITH SEVERE MEDICATION-RESISTANT CD. SEVERITY OF HEAD AND NECK DEVIATION, DISABILITY, AND PAIN RELATED TO DYSTONIA WERE ASSESSED BY THE TORONTO WESTERN SPASMODIC TORTICOLLIS RATING SCALE (TWSTRS) IN THE FRAME OF A PROSPECTIVE STUDY. REPORTED EVENTS: ONE PATIENT EXPERIENCED AN INFECTION AT THE INCISION SITE TWO YEARS AFTER THE OPERATION. SURGICAL WOUND REVISION WITHOUT REPLACING THE ELECTRODE RESULTED IN FULL RECOVERY. ONE PATIENT EXPERIENCED HARDWARE RELATED COMPLICATIONS IN WHICH THEY HAD 3 CONSECUTIVE LEAD FRACTURES. TWO OF THESE WERE ON THE RIGHT, AND ONE WAS ON THE LEFT. THE LEAD FRACTURES WERE FOLLOWED BY A DETERIORATION OF DYSTONIA. THE LEADS WERE EXPLANTED AND REPLACED. THE REVISIONS RESULTED IN FULL RECOVERY. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7146 IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention