BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 5698131 · Received June 3, 2016

    Report

    Report Number
    2938836-2016-04576
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 13, 2016
    Report Date
    October 1, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PMA# SHOULD HAVE BEEN P030054 RATHER THAN BLANK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN FELT THAT THE BATTERY LONGEVITY ESTIMATE WAS TOO LOW DURING AN IN-CLINIC FOLLOW-UP. THE PATIENT WAS STABLE. PROGRAMMING CHANGES WERE MADE AND THE BATTERY LONGEVITY READING WAS IMPROVED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352733 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3371-40QC P000018718

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR