BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA ICD

    MDR report key: 5311244 · Received December 18, 2015

    Report

    Report Number
    2938836-2015-32450
    Event Type
    Injury
    Date Received
    December 18, 2015
    Date of Event
    October 18, 2015
    Report Date
    October 21, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED IN THE CLINIC WITH NON-SUSTAINED VT AND NON-SUSTAINED VENTRICULAR OVERSENSING EPISODES. FURTHER REVIEW OF THE EPISODES APPEARED TO BE DUE TO OVERSENSING EMI ON THE VENTRICULAR CHANNEL. PROGRAMMING CHANGES WERE RECOMMENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED IN THE CLINIC WITH NON-SUSTAINED VT AND NON-SUSTAINED VENTRICULAR OVERSENSING EPISODES. FURTHER REVIEW OF THE EPISODES APPEARED TO BE DUE TO OVERSENSING EMI ON THE VENTRICULAR CHANNEL. PROGRAMMING CHANGES WERE RECOMMENDED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ADDITIONAL EPISODES OF NON-SUSTAINED RV OVERSENSING AND EPISODE OF VF THAT DELIVERED INAPPROPRIATE ANTITACHYCARDIA PACING THERAPY WERE OBSERVED. NOISE WAS REPRODUCED WITH DEEP BREATHING. PROGRAMMING CHANGES WERE MADE HOWEVER, A FEW MORE OVERSENSING WAS OBSERVED. ADDITIONAL PROGRAMMING CHANGE WAS MADE AND MEDICATION WAS ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836625 UNIFY ASSURA ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3361-40C S000005513

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention