BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DDQP+

    MDR report key: 5756258 · Received June 28, 2016

    Report

    Report Number
    2938836-2016-05477
    Event Type
    Malfunction
    Date Received
    June 28, 2016
    Date of Event
    May 31, 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
    PHYSICAL THERAPIST

    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

    CORRECTION: IT WAS REPORTED THAT EPISODES ON NON-SUSTAINED RV OVERSENSING WERE NOTED. REVIEW OF THE EPISODES REVEALED MYOPOTENTIAL OVERSENSING. PERFORMING ISOMETRICS AND DEEP BREATHING TO REPRODUCE OVERSENSING AND PROGRAMMING CHANGES WERE RECOMMENDED. INDUCTION TEST SHOULD BE ALSO CONSIDERED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THE PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EPISODES ON NON-SUSTAINED RV OVERSENSING WERE NOTED. REVIEW OF THE EPISODES REVEALED MYOPOTENTIAL OVERSENSING. PERFORMING ISOMETRICS AND DEEP BREATHING TO REPRODUCE OVERSENSING AND PROGRAMMING CHANGES WERE RECOMMENDED. INDUCTION TEST SHOULD BE ALSO CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408328 UNIFY ASSURA DDQP+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3261-40 3974986

    Patients

    Seq Age Sex Outcome Treatment
    1