BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA

    MDR report key: 3210528 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03391
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 22, 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
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF NON-SUSTAINED LEAD NOISE WAS CONFIRMED VIA REVIEW OF STORED ELECTROGRAMS. CROSSTALK WAS INTERMITTENTLY PRESENT ON THE VENTRICULAR SENSE CHANNEL. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE FOUND. NOISE WAS NOT REPRODUCED DURING TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING A PATIENT NOTIFIER FOR NON-SUSTAINED LEAD NOISE EPISODES DUE TO INTERMITTENT CROSSTALK. THE CROSSTALK WAS SEEN ON THE V SENSE AMP AND WAS NOT PRESENT ON THE DISCRIMINATOR CHANNEL. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310897 FORTIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention (B)(4)