BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILOS DR

    MDR report key: 578113 · Received November 2, 2005

    Report

    Report Number
    1028232-2005-00020
    Event Type
    Other
    Date Received
    November 2, 2005
    Report Date
    February 2, 2005
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEVICE RETURNED IN ERI FROM ST. JUDE MEDICAL. INTERROGATION SHOWS BATTERY VOLTAGE AT 2.78V.

    Description of Event or Problem · 1

    DEVICE RETURNED IN ERI FROM ST. JUDE MEDICAL. INTERROGATION SHOWS BATTERY VOLTAGE AT 2.78V.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization