BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELOS VR-T

    MDR report key: 474637 · Received July 24, 2003

    Report

    Report Number
    1028232-2003-00243
    Event Type
    Malfunction
    Date Received
    July 24, 2003
    Date of Event
    March 21, 2003
    Report Date
    July 18, 2003
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    VOLUNTARY FIRM INITIATED DEVICE PATIENT MANAGEMENT INFORMATION (PMI) IN 2003 THE MANUFACTURER NOTIFIED BIOTRONIK, INC THAT PRODUCT WAS SUBJECT TO THE ATTACHED MANUFACTURER TECHNICAL NOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELOS VR-T ICD MKJ BIOTRONIK GMBH & CO. 331 135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening