BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA ICD

    MDR report key: 6181792 · Received December 16, 2016

    Report

    Report Number
    2938836-2016-18418
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 29, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION RECEIVED, THE DEVICE WAS PROPHYLACTICALLY REMOVED AND THERE IS NO ALLEGED MALFUNCTION OF THE PRODUCT. SHOULD THE DEVICE BE RETURNED AND THE ANALYSIS RESULTS INDICATE AN ANOMALY A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    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.

    Description of Event or Problem · 1

    FSCA PREMATURE BATTERY DEPLETION WITH ICD ¿ (B)(6) 2016. THE PHYSICIAN DR (B)(6) DECIDED TO REPLACE THE DEVICE UNIFY ASSURA MP 3361-40C SN: (B)(4), IMPLANTED ON (B)(6) 2014, BECAUSE THE PATIENT HAD SOME HIGH VOLTAGE THERAPIES ON VENTRICULAR TACHYCARDIAS. THE DEVICE WAS WORKING NORMALLY. THE PATIENT'S CONDITIONS BEFORE, DURING AND AFTER THE PROCEDURE WERE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832753 UNIFY ASSURA ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3361-40C 4636304

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention