BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 188822 · Received September 10, 1998

    Report

    Report Number
    2183613-1998-00009
    Event Type
    Injury
    Date Received
    September 10, 1998
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S BLOOD PRESSURE DROPPED AND IT WAS NOTED THE PACEMAKER WAS ONLY V PACING. THE PACE/SENSE LIGHTS INDICATED (A-SENSE/V-PACE). NO P-WAVES ON ECG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 000 Other