BEUDAMED
    FDA Adverse Event Other Summary report: N

    BELOS DR

    MDR report key: 502679 · Received September 30, 2003

    Report

    Report Number
    1028232-2003-00291
    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 ASSOCIATED WITH PT MANAGEMENT INFO (PMI). THE MFR NOTIFED BIOTRONIK, INC. THAT PRODUCT WAS SUBJECT TO THE ATTACHED DEAR DOCTOR LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELOS DR ICD LWS BIOTRONIK GMBH & CO. 338 170 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization