BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2183613-1999-00013

    MDR report key: 265362 · Received September 8, 1999

    Report

    Report Number
    2183613-1999-00013
    Event Type
    Injury
    Date Received
    September 8, 1999
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DEVICE SUDDENLY SHUT OFF WHILE IN USE. PATIENT WAS PACER DEPENDANT AND REQUIRED CPR AS A RESULT OF THE DEVICE NOT PACING. A NEW DEVICE WAS ATTACHED TO PATIENT AND PACING RESUMED. IT IS REPORTED THAT THE PATIENT IS DOING FINE WITHOUT INJURY.

    Patients

    Seq Age Sex Outcome Treatment
    1 000 Other