BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ST VR

    MDR report key: 3090132 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01165
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 11, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD REPORTED EVENT OF HIGH IMPEDANCE MEASUREMENTS WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED TEST EQUIPMENT SYSTEM. NO ANOMALY WAS FOUND. THE CAUSE OF THE FIELD REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT FOR HIGH PACING LEAD IMPEDANCE WAS RECEIVED VIA (B)(6). PREVIOUS AND IN-CLINIC MEASUREMENTS SHOWED NORMAL. THE ICD WAS EXPLANTED, AND LEAD WAS CAPPED AFTER BEING MONITORED AND AGAIN SHOWED HIGH MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191209 FORTIFY ST VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1235-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4) (B)(4)