BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 6183753 · Received December 16, 2016

    Report

    Report Number
    2938836-2016-18653
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW UP WHEN POST PACED T WAVE OVERSENSING WAS OBSERVED. PROGRAMMING CHANGES WERE RECOMMENDED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATES THAT THAT ANOTHER INSTANCE OF POST PACED T WAVE OVERSENSING WAS OBSERVED. FURTHER PROGRAMMING CHANGES WERE IMPLEMENTED. THE PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833813 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3371-40QC S000004461

    Patients

    Seq Age Sex Outcome Treatment
    1