BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR

    MDR report key: 3220335 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04417
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    February 8, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FAILURE (EVENT) OBSERVED DURING ANALYSIS. THE REPORTED FIELD EVENT OF OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENTS WAS CONFIRMED IN THE LABORATORY. DURING BENCH TESTING, IT WAS FOUND THAT THE IMPEDANCE MEASUREMENT FUNCTION OF THE DEVICE WAS PROVIDING INCORRECT VALUES DUE TO A SUSPECTED CIRCUIT FAILURE. THE FAILURE WAS LOST AFTER THE DEVICE WAS TESTED USING AUTOMATED TEST EQUIPMENT AND COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OUT OF RANGE IMPEDANCE MEASUREMENTS WERE OBSERVED ON STORED RECORDS. THE PATIENT HAD UNDERGONE MULTIPLE PERIODS OF DIALYSIS WHICH COINCIDED WITH THE OUT OF RANGE MEASUREMENTS. ALL MEASUREMENTS WHEN TESTED IN CLINIC WERE NORMAL. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320931 FORTIFY VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention