BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA DDQP+

    MDR report key: 7053470 · Received November 22, 2017

    Report

    Report Number
    2017865-2017-34964
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    October 8, 2017
    Report Date
    September 26, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    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

    PMA/510K # SHOULD HAVE BEEN P030054 RATHER THAN BLANK.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED NON SUSTAINED RIGHT VENTRICULAR OVERSENSING DUE TO POST PACED T-WAVE OVERSENSING. THE OVERSENSING WAS NOTED ON A STORED ELECTROGRAM. THE DEVICE WAS REPROGRAMMED ON (B)(6) 2017 AND THE COMPLAINT WAS RESOLVED. THE PATIENT'S CONDITION WAS FINE POST EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831907 QUADRA ASSURA DDQP+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3267-40Q 4352138

    Patients

    Seq Age Sex Outcome Treatment
    1