BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUIDANT PACEMAKER, INSIGNIA PLUS

    MDR report key: 1673416 · Received May 1, 2010

    Report

    Report Number
    MW5015763
    Event Type
    Death
    Date Received
    May 1, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 1, 2010
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT BECAME WEAK AT HOME THEN PASSED OUT. EMS WAS CALLED AND WAS PULSELESS UPON THEIR ARRIVAL. (B) (6) PROTOCOL ENSUED WITHOUT SUCCESS. NO PACER SPIKES ARE NOTED ON THE RHYTHM STRIPS. DATES OF USE: (B) (6) 2005. DIAGNOSIS OR REASON FOR USE: FAMILY DOESN'T KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT PACEMAKER, INSIGNIA PLUS NONE DXY F09B

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death