BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACESETTER, INC.

    MDR report key: 1010510 · Received February 15, 2008

    Report

    Report Number
    1010510
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    June 19, 2007
    Report Date
    January 14, 2008
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BROUGHT INTO THE OFFICE FOR ERI (ELECTIVE REPLACEMENT INTERVAL CONFIRMATION ON THE PACEMAKER. DURING THE INTERROGATION, THE PACESETTER, INC. TECHNICAL SERVICES WAS CONTACTED DUE TO CONFLICTING INFORMATION REGARDING THE BATTERY'S IMPEDANCE, CURRENT, AND VOLTAGE. THE PACEMAKER WAS SENT INTO THE COMPANY FOR INTERROGATION AFTER EXPLANTATION. PER ST. JUDE MEDICAL'S QUALITY ASSURANCE DEPARTMENT, THE DEVICE HAD AN EPOXY BOND ANOMALY, WHICH RESULTED IN BATTERY'S IMPEDANCE MEASUREMENT ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACESETTER, INC. PACEMAKER DXY ST. JUDE MEDICAL, INC. 5330R *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR