BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA ICD

    MDR report key: 6056276 · Received October 25, 2016

    Report

    Report Number
    2938836-2016-13353
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED TO CLINIC FOR ROUTINE FOLLOW-UP, POST-PACED T-WAVE OVERSENSING WAS OBSERVED ON THE VENTRICULAR CHANNEL. PATIENT DID NOT RECEIVE THERAPY DURING THE OVERSENSING. PROGRAMMING CHANGES WERE RECOMMENDED AND SCHEDULED FOR NEXT FOLLOW-UP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706546 QUADRA ASSURA ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3367-40QC 4901003

    Patients

    Seq Age Sex Outcome Treatment
    1