BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA VR ICD_IDE_US

    MDR report key: 6679628 · Received June 29, 2017

    Report

    Report Number
    2017865-2017-05848
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    June 21, 2017
    Report Date
    April 2, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    PMA / PMN Number
    P910023/S338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED ON (B)(6) 2018 NOTES THAT THERE WERE MORE INSTANCES OF WIDE QRS COMPLEXES ON PATIENT'S MERLIN.NET TRANSMISSION. SOME OF THESE WIDE QRS EPISODES WERE BINNED AS VENTRICULAR FIBRILLATION (VF). THERE WERE NO INAPPROPRIATE SHOCKS. PROGRAMMING CHANGES WERE SUGGESTED. FURTHER INFORMATION COULD NOT BE OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS DOUBLE COUNTING WIDE QRS COMPLEXES AND BINNING IN THE VENTRICULAR FIBRILLATION ZONE. THE EPISODES WERE STORED AS NON-SUSTAINED VENTRICULAR TACHYCARDIA. HOWEVER, NO IN-APPROPRIATE SHOCKS WERE DELIVERED. PROGRAMMING CHANGES WERE MADE TO RAISE THE VENTRICULAR FIBRILLATION ZONE. PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED NORMALLY.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED ON 03/30/2018 NOTES THAT THERE WERE NO PROGRAMMING CHANGES MADE TO THE PREVIOUSLY REPORTED INSTANCES OF WIDE QRS COMPLEXES. PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459769 FORTIFY ASSURA VR ICD_IDE_US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD1257-40 3696674

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR