BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6283208 · Received January 27, 2017

    Report

    Report Number
    9614453-2017-00017
    Event Type
    Injury
    Date Received
    January 27, 2017
    Date of Event
    September 17, 2016
    Report Date
    March 9, 2017
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM, OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3389-28, LOT# 0208479328, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2016, PRODUCT TYPE LEAD. PRODUCT ID 3389-28, LOT# 0208479331, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2016, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP). IT WAS REPORTED THAT THE CAUSE OF THE INFECTION WAS UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AROUND THE LEADS AND THE PATIENT'S LEAD SCAR. THE DIAGNOSTIC METHODS INCLUDED LABORATORY TESTING ON (B)(6) 2016 THAT RESULTED IN "SAMS AND EPIDERMIDIS OXAR BACTRIMS RIFA AND OFLOP ". INTERVENTIONS INCLUDED EXPLANTING THE ENTIRE SYSTEM ON (B)(6) 2016 AND ADMINISTERING MEDICATIONS; THE PATIENT WAS HOSPITALIZED AS THE EVENT RESULTED IN A LIFE-THREATENING ILLNESS OR INJURY. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. THE ETIOLOGY WAS POSSIBLY RELATED TO THE DEVICE/THERAPY, BUT NOT RELATED TO THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65923 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC EUROPE SARL 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R