BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAGLITE 25

    MDR report key: 433550 · Received November 14, 2002

    Report

    Report Number
    9613232-2002-00001
    Event Type
    Other
    Date Received
    November 14, 2002
    Date of Event
    October 16, 2002
    Report Date
    October 16, 2002
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Product Code
    GWF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN EVOKED POTENTIAL EXAMINATION, A COMPANION PERSON WAS PRESENT IN THE ROOM. AT THE END OF THE EXAMINATION THE COMPANION NOTED HEAVY BREATHING. PT WAS SENT TO THE CARDIOLOGY DEPARTMENT WHERE IT WAS NOTED THAT THEIR PACEMAKER PROGRAM HAD RESET. THE PACEMAKER WAS REPROGRAMMED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGLITE 25 MAGNETIC STIMULATOR GWF MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S 9016E0831 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other