BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTION AFM

    MDR report key: 635921 · Received May 10, 2005

    Report

    Report Number
    6000095-2005-00013
    Event Type
    Injury
    Date Received
    May 10, 2005
    Date of Event
    March 4, 2005
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PREMATURE BATTERY DEPLETION

    Description of Event or Problem · 1

    CANNOT COMMUNICATE WITH DEVICE; MAGNET RATE 75 BPM REPORTED. DEVICE LATER RETURNED FOR PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTION AFM IMPLANTABLE PULSE GENERATOR DXY VITATRON MEDICAL B.V. 902 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other