BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 11695838 · Received April 20, 2021

    Report

    Report Number
    2017865-2021-13526
    Event Type
    Death
    Date Received
    April 20, 2021
    Date of Event
    March 27, 2021
    Report Date
    April 20, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734508377
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-13334, 2017865-2021-13527, 2017865-2021-13528. IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY ON (B)(6) 2021 WITH THEIR RIGHT VENTRICULAR LEAD EXHIBITING NOISE LEADING TO NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING. THE PATIENT PASSED AWAY ON (B)(6) 2021 BEFORE AN IN-PERSON DEVICE CHECK COULD BE DONE. THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594509 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000052167 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death OPTISURE| QUARTET| TENDRIL STS