BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 4831839 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01587
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 27, 2015
    Report Date
    March 27, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A GENERAL COMPLAINT FOR HIGH POWER DEVICES WAS REPORTED THAT RELATED TO DETECTION CRITERIA AND DISCRIMINATOR PROGRAMMING IN THE PRESENCE OF CHRONIC AF (ATRIAL FIBRILLATION). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374620 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE LWS MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention