BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA DDQP+

    MDR report key: 7789929 · Received August 16, 2018

    Report

    Report Number
    2017865-2018-11939
    Event Type
    Injury
    Date Received
    August 16, 2018
    Date of Event
    July 24, 2018
    Report Date
    January 24, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z-0004-2018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF A BATTERY PERFORMANCE ALERT (BPA) WAS CONFIRMED VIA REVIEW OF DEVICE IMAGE. THE ALERT WAS DUE TO A TRANSIENT DROP IN THE BATTERY VOLTAGE THAT IS CONSISTENT WITH BATTERY DEPLETION ASSOCIATED WITH LITHIUM CLUSTERS. HOWEVER, SINCE THE MONTHLY BATTERY VOLTAGE TREND AND THE OVERALL EXPECTED LONGEVITY OF THE DEVICE WAS NORMAL, PREMATURE BATTERY DEPLETION COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    CORRECTION: SECTION OF THE INITIAL REPORT SHOULD HAVE INCLUDED PMA/ NUMBER P030054.

    Description of Event or Problem · 1

    FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND AWAITING EXPLANT. FURTHER INFORMATION WAS REQUESTED, BUT NOT YET AVAILABLE.

    Description of Event or Problem · 1

    NEW INFORMATION REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED ON AN UNKNOWN DATE. THE PATIENT WAS STABLE DURING AND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630952 QUADRA ASSURA DDQP+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3267-40Q 4165037

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention