BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY DR

    MDR report key: 636389 · Received August 31, 2005

    Report

    Report Number
    636389
    Event Type
    Injury
    Date Received
    August 31, 2005
    Date of Event
    August 29, 2005
    Report Date
    August 31, 2005
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS PRESENTED TO CARDIOLOGY OFFICE FOR A ROUTINE PACEMAKER CHECK. IT WAS DETERMINED THAT THE VENTRICULAR FUNCTIONING VVI PACEMAKER WAS AT 67 BPM, BEATS PER MINUTE. THE UNDERLYING RHYTHM WAS A-FIB BY EKG. THERE WAS EVIDENCE OF INCOMPLETE CAPTURE. THE PACEMAKER GENERATOR BATTERY WAS THOUGHT TO BE AT THE END OF THE BATTERY LIFE. PATIENT TO OR FOR A PACEMAKER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY DR PACEMAKER DXY ST. JUDE MEDICAL 5370 DDDR *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R