BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1970229 · Received January 25, 2011

    Report

    Report Number
    2124215-2010-21987
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    February 2, 2009
    Report Date
    February 2, 2009
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTRICULAR LEAD REMAINS IN SERVICE WITH THE NEW PACEAMKER AND NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NINE MONTHS AGO, THIS PATIENT WITH THIS PACEMAKER PRESENTED TO THE EMERGENCY DEPARTMENT WITH SYMPTOMS OF FATIGUE, DIZZINESS AND NEAR SYNCOPE. IT WAS NOTED THAT THE PATIENT HAD A VIRAL INFECTION WHICH CAUSED THEIR THRESHOLD MEASUREMENTS TO INCREASE. A HEART MONITOR SHOWED VENTRICULAR LOSS OF CAPTURE WITH HEART RATES IN THE 30 BPM RANGE. THE PATIENT WAS THEN TRANSFERRED TO THE ICU. AT THAT TIME, A BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) WAS PRESENT AND INTERROGATED THE DEVICE. PACING OUTPUTS WERE INCREASED DUE TO THE INCREASED THRESHOLD MEASUREMENTS. SEVEN MONTHS FOLLOWING THIS INCIDENT, THE PATIENT'S PACEMAKER WAS EXPLANTED AND REPLACED FOR NORMAL BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening 1290| 4456| 4086