BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILOS DR

    MDR report key: 557685 · Received November 22, 2004

    Report

    Report Number
    1028232-2004-00135
    Event Type
    Other
    Date Received
    November 22, 2004
    Date of Event
    November 5, 2004
    Report Date
    November 17, 2004
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PULSE GENERATOR INTERROGATES ERI. CLINICIAN COMPLAINT 'UNABLE TO PROGRAM PACING OUTPUT'. INTERROGATION BY BIOTRONIK INDICATES BATTERY STATUS ERI AND BATTERY VOLTAGE 2.68V.

    Description of Event or Problem · 1

    PULSE GENERATOR INTERROGATES ERI. CLINICIAN COMPLAINT 'UNABLE TO PROGRAM PACING OUTPUT'. INTERROGATION BY BIOTRONIK INDICATES BATTERY STATUS ERI AND BATTERY VOLTAGE 2.68V.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS DR PACEMAKER DTB BIOTRONIK GMBH & CO. 331 443 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization