BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURE QUADRA RF CRT-P

    MDR report key: 6207535 · Received December 27, 2016

    Report

    Report Number
    2017865-2016-08014
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NKE
    PMA / PMN Number
    P970013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON ATTEMPTED INTERROGATION, THE PULSE GENERATOR EXHIBITED RF TELEMETRY ANOMALY. A DEVICE FIRMWARE WAS DOWNLOADED AND RESUMED NORMAL FUNCTIONS. THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857578 ALLURE QUADRA RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR NKE ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM3242 A000020589

    Patients

    Seq Age Sex Outcome Treatment
    1