BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA ICD

    MDR report key: 5221652 · Received November 13, 2015

    Report

    Report Number
    2938836-2015-31539
    Event Type
    Injury
    Date Received
    November 13, 2015
    Date of Event
    October 19, 2015
    Report Date
    October 19, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN AN ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING PATIENT NOTIFIER, THE DEVICE WAS FOUND TO BE IN RESET MODE. RECORDS DISCOVERED THE PATIENT HAD RECEIVED INAPPROPRIATE SHOCK THERAPY. THE ISSUE WAS RESOLVED AFTER INSTALLING A DEVICE DOWNLOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752210 UNIFY ASSURA ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3257-40 3700640

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention