BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA ICD

    MDR report key: 6236268 · Received January 10, 2017

    Report

    Report Number
    2938836-2017-02157
    Event Type
    Injury
    Date Received
    January 10, 2017
    Date of Event
    December 14, 2016
    Report Date
    October 30, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).BASED ON THE INFORMATION RECEIVED, THE DEVICE WAS PROPHYLATICALLY 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).

    Additional Manufacturer Narrative · 1

    CORRECTION: - PMA NUMBER P030054 SHOULD HAVE BEEN REPORTED IN INITIAL REPORT.

    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
    21471 UNIFY ASSURA ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC CD3361-40C 4548696

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention