BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA MP ICD

    MDR report key: 6251385 · Received January 13, 2017

    Report

    Report Number
    2938836-2017-03318
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 20, 2018
    Report Date
    September 28, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE EVENT DATE SHOULD BE (B)(6) 2016 RATHER THAN (B)(6) 2017. PMA/510(K) # SHOULD HAVE BEEN P030054.

    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.

    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
    31713 UNIFY QUADRA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3255-40Q 4315315

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention