BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST. JUDE MEDICAL - PACESETTER

    MDR report key: 436290 · Received January 3, 2003

    Report

    Report Number
    MW1027157
    Event Type
    Death
    Date Received
    January 3, 2003
    Date of Event
    January 17, 2002
    Report Date
    December 10, 2002
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A SERIES OF DEVICE DISCHARGES FOR SUSTAINED VT. THE DEVICE DELIVERED 4 APPROPRIATE SHOCK'S AND 3 DAYS LATER HAD WORE VT AND THE DEVICE DELIVERED THERAPY, HOWEVER, HI VOLTAGE IMPEDANCE MEASURED >200 OHMS. IT IS BELIEVED THAT THERE WAS A FRACTURE TO THE LEAD THAT CAUSED EXCESSIVE WORSE DETECTION AND DESTRUCTION OF THE CAN. PT INTERRED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL - PACESETTER PHOTON DR LWS ST. JUDE MEDICAL V-230HV *
    2 ST. JUDE MEDICAL - PACESETTER PHOTON DR LWS ST. JUDE MEDICAL VENTRITEX 1559/65CM *
    3 ST. JUDE MEDICAL - PACESETTER PHOTON DR LWS ST. JUDE MEDICAL PACETTER 1488T *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death