BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA CRT-D RF HV

    MDR report key: 7186160 · Received January 12, 2018

    Report

    Report Number
    2017865-2018-00633
    Event Type
    Injury
    Date Received
    January 12, 2018
    Date of Event
    December 19, 2017
    Report Date
    May 17, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ADVISORY NOTICE ISSUED BY ST. JUDE MEDICAL ON 11 OCTOBER 2016.

    Additional Manufacturer Narrative · 1

    INTERROGATION OF THE DEVICE REVEALED IT WAS ABOVE ERI WHEN RECEIVED. BASED ON THIS INFORMATION, THE DEVICE WAS FOUND TO COMMUNICATE APPROPRIATELY WITH A MERLIN PROGRAMMER AND HAS NOT REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE IS INCLUDED IN THE PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ADVISORY NOTICE ISSUED BY ST. JUDE MEDICAL ON 11 OCTOBER 2016.

    Description of Event or Problem · 1

    FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ALTHOUGH THERE WAS NO ERI ALERT OR ALLEGATION OF PREMATURE BATTERY DEPLETION, THE DEVICE WAS EXPLANTED PROPHYLACTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29518 UNIFY ASSURA CRT-D RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3357-40C 4192704

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R