BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA ICD

    MDR report key: 6407773 · Received March 15, 2017

    Report

    Report Number
    2938836-2017-18537
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    November 23, 2016
    Report Date
    October 8, 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

    CORRECTION: SECTION PMA/510(K) # WAS INITIALLY BLANK AND SHOULD HAVE BEEN P030054. SECTION CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES WAS INITIALLY BLANK AND SHOULD HAVE BEEN 1888TC/52, (B)(4) AND 1058T/86, (B)(4) WITH THERAPY DATES OF (B)(6)2016.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP RV OVERSENSING LEADING TO INHIBITION OF PACING WAS OBSERVED VIA REVIEWS OF ELECTROGRAMS. NO INTERVENTION WAS PERFORMED. PATIENT MONITORING WILL CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187479 UNIFY ASSURA ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3361-40C 4231943

    Patients

    Seq Age Sex Outcome Treatment
    1