BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUARTET

    MDR report key: 11856592 · Received May 20, 2021

    Report

    Report Number
    2017865-2021-18636
    Event Type
    Death
    Date Received
    May 20, 2021
    Date of Event
    July 19, 2019
    Report Date
    May 20, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734503198
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    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: 2017865-2021-18633, 2017865-2021-18638. IT WAS REPORTED THAT WHEN A MECHANICAL SAW WAS BEING USED TO AMPUTATE THE PATIENT¿S LEG IN A PROCEDURE ON (B)(6) 2019, LOSS OF CARDIAC PACING WAS OBSERVED DUE TO NOISE OVERSENSING FROM THE SAW RESULT IN PACING INHIBITION. THE PATIENT WAS PACEMAKER DEPENDENT. THE PATIENT BECAME SEVERELY BRADYCARDIA, HYPERTENSIVE AND WENT INTO CARDIAC ARREST. THE PATIENT SUFFERED INJURY TO THE BRAIN DUE TO ANOXIC ENCEPHALOPATHY. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND REMAINED NON-RESPONSIVE AT THIS FACILITY. THE PATIENT EXPIRED (B)(6) JUL 2019 AS A NATURAL CONSEQUENCE OF SEVERE ANOXIC ENCEPHALOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753377 QUARTET PERMANENT PACEMAKER ELECTRODE NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1458Q/86 A000002188 05414734503198

    Patients

    Seq Age Sex Outcome Treatment
    1 Death QUADRA ASSURA CRT-D QUAD RF HV| TENDRIL ST