BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 11925365 · Received June 2, 2021

    Report

    Report Number
    2017865-2021-20226
    Event Type
    Death
    Date Received
    June 2, 2021
    Report Date
    August 6, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734508377
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF UNDERSENSING AND HV OUTPUT ANOMALY COULD NOT BE CONFIRMED IN THE LAB. ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 0

    CORRECTION - B5 AND H6 CORRECTED FOR CAUSE OF DEATH DUE TO FAILURE TO DELIVER SHOCK INSTEAD OF UNKNOWN.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-22191 IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE WAS SUSPICION THAT THE CAUSE OF DEATH WAS THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND RIGHT VENTRICULAR LEAD FAILED TO DELIVER HIGH VOLTAGE THERAPY FOR VENTRICULAR FIBRILLATION.

    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

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822385 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000101509 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death LDA210Q/58 OPTISUREMRI LEADS UMRI PR