BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DDQP+

    MDR report key: 5227872 · Received November 16, 2015

    Report

    Report Number
    2938836-2015-31528
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    October 7, 2015
    Report Date
    October 3, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: UDI - (B)(4) SHOULD HAVE BEEN SUBMITTED IN INITIAL REPORT. CORRECTION: - PMA/510(K) # - P030054 SHOULD HAVE BEEN SUBMITTED IN INITIAL REPORT. CORRECTION: - 'USER FACILITY' SHOULD HAVE BEEN SELECTED IN INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-SUSTAINED RV OVERSENSING DUE TO POST-PACED T-WAVE OVERSENSING WAS OBSERVED ON STORED EGM WHEN AN ASYMPTOMATIC PATIENT PRESENTED THROUGH MERLIN.NET TRANSMISSION. THE PATIENT DID NOT RECEIVE ANY THERAPY DURING THE OVERSENSING. PROGRAMMING CHANGES WERE SUGGESTED. PATIENT WILL CONTINUE TO BE MONITORED THROUGH MERLIN.NET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757528 UNIFY ASSURA DDQP+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3261-40 3885705

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR