BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 6113465 · Received November 18, 2016

    Report

    Report Number
    2938836-2016-14441
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED WITH DEVICE EXHIBITING POST-PACED T-WAVE OVERSENSING. THE PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE MADE DURING THE DEVICE CHECK.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATED THAT ANOTHER OCCURRENCE OF POST-PACED T-WAVE OVERSENSING WAS OBSERVED WHEN PATIENT PRESENTED TO THE CLINIC FOR FOLLOW-UP. PROGRAMMING CHANGES WERE MADE DURING THE DEVICE CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764142 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3369-40Q A000024624

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR