BEUDAMED
    FDA Adverse Event Other Summary report: N

    BELOS VR

    MDR report key: 487341 · Received September 30, 2003

    Report

    Report Number
    1028232-2003-00292
    Event Type
    Other
    Date Received
    September 30, 2003
    Date of Event
    September 24, 2003
    Report Date
    September 25, 2003
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    VOLUNTARY FIRM INITIATED DEVICE RECALL EXTENSION IN 2003 ASSCOCIATED WITH PT MANAGEMENT INFO (PMI). THE MFR NOTIFIED BIOTRONIK, INC THAT PRODUCT WAS SUBJECT TO A DEAR DOCTOR LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELOS VR ICD LWS BIOTRONIK GMBH & CO. 330 444 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization