BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSIGNIA PLUS

    MDR report key: 637829 · Received February 9, 2004

    Report

    Report Number
    2124215-2004-06433
    Event Type
    Death
    Date Received
    February 9, 2004
    Date of Event
    October 19, 2003
    Report Date
    October 19, 2003
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER EXPIRED SECONDARY TO A SUSPECTED PULMONARY EMBOLISM. THE PHYSICIAN WHO WAS PRESENT STATED THAT HE DID NOT SEE PACING SPIKES ON THE SURFACE EKG MONITOR. THE DEVICE WAS SUCCESSFULLY INTERROGATED IN THE MORGUE, AND NO ABNORMALITIES WERE OBSERVED. IMPEDANCE AND DAILY MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DATA WAS SAVED TO A DISK, WHICH WAS RETURNED FOR ANALYSIS ALONG WITH THE PRINTOUTS FROM THE INTERROGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA PLUS IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1194 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death