BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY QUADRA CRT-D

    MDR report key: 3339855 · Received September 10, 2013

    Report

    Report Number
    2938836-2013-06441
    Event Type
    Malfunction
    Date Received
    September 10, 2013
    Date of Event
    June 1, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED A SHORTNESS OF BREATH SINCE DEVICE IMPLANT. MEDICINE DOSAGE WAS CHANGED BUT IT DID NOT HELP. REPROGRAMMING THE DEVICE WAS PERFORMED. THE PATIENT WILL BE RECHECKED IN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452141 UNIFY QUADRA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3249-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR