BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA CRT-D QUAD RF HV

    MDR report key: 6199111 · Received December 22, 2016

    Report

    Report Number
    3006705815-2016-00703
    Event Type
    Injury
    Date Received
    December 22, 2016
    Report Date
    December 15, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 AND ANOMALY, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED PROPHYLACTICALLY FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO ISSUE WAS REPORTED REGARDING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850999 QUADRA ASSURA CRT-D QUAD RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3365-40Q 4501990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention