BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8713823 · Received June 19, 2019

    Report

    Report Number
    3007566237-2019-01343
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    December 3, 2018
    Report Date
    June 19, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. THE REPORTED EVENTS WERE FROM THE FOLLOWING LITERATURE ARTICLE AND ITS ACCOMPANYING SUPPLEMENTAL MATERIAL: BRÜGGEMANN N, DOMINGO A, RASCHE D, MOLL CKE, ROSALES RL, JAMORA RDG, HANSSEN H, MÜNCHAU A, GRAF J, WEISSBACH A, TADIC V, DIESTA CC, VOLKMANN J, KÜHN A, MÜNTE TF, TRONNIER V, KLEIN C. ASSOCIATION OF PALLIDAL NEUROSTIMULATION AND OUTCOME PREDICTORS WITH X-LINKED DYSTONIA PARKINSONISM. JAMA NEUROLOGY. PUBLISHED ONLINE DECEMBER 03, 2018; 76(2):211-216. DOI: 10.1001/JAMANEUROL.2018.3777. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE REPORTED IN LITERATURE- REPORTED EVENT: PATIENT: L-8313 ¿ ONE (B)(6) YEAR-OLD PATIENT WITH BILATERAL INTERNAL GLOBUS PALLIDUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR X-LINKED DYSTONIA PARKINSONISM (XPD) EXPERIENCED SURGERY-RELATED HEMATOMA AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. IT WAS UNCLEAR IF THE HEMATOMA REQUIRED ASPIRATION. THE PATIENT ALSO EXPERIENCED POSTOPERATIVE CONFUSION AND TRANSIENT ANEMIA DUE TO UROGENITAL HEMORRHAGE RELATED TO THE OPERATION. THESE SURGERY-RELATED ADVERSE EVENTS RESOLVED WITHOUT SEQUELAE. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: ACTIVA PC IMPLANTABLE NEUROSTIMULATOR; LEAD MODEL 3387.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506648 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention