BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D, US MODEL, DF4COMP

    MDR report key: 6119621 · Received November 21, 2016

    Report

    Report Number
    2938836-2016-14619
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT NOTIFIER ANOMALY COULD NOT BE CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC AFTER RECEIVING A PATIENT NOTIFICATION ALERT. UPON OBSERVATION BY PHYSICIAN, DEVICE WAS UNABLE TO VIBRATE. PATIENT IS DEPENDENT ON THE PATIENT NOTIFIER AND HAS HAD NO EXPOSURE TO MRI. DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED. PATIENT WAS STABLE POST PROCEDURE.

    Description of Event or Problem · 1

    DEVICE IS UNDER BATTERY ADVISORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767555 UNIFY QUADRA CRT-D, US MODEL, DF4COMP IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3249-40Q 3818050

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention