BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIRM

    MDR report key: 10541686 · Received September 16, 2020

    Report

    Report Number
    2017865-2020-13697
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    August 26, 2020
    Report Date
    November 30, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    MXC
    UDI-DI
    05415067027320
    PMA / PMN Number
    K163407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF PREMATURE BATTERY DEPLETION WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE¿S SESSION RECORD WAS REVIEWED WHICH SHOWED THE DEVICE EXITED SHIPPED SETTING ON JUNE 1ST, 2020, 63 WEEKS PRIOR TO IMPLANT. THERE WAS APPROXIMATELY 1% USAGE PER WEEK AFTER THE DEVICE EXITED SHIPPED SETTINGS. THE REMAINING BATTERY CAPACITY AT THE TIME OF IMPLANT SHOULD BE AT 40%. AN ASSESSMENT OF TOTAL PROJECTED LONGEVITY WAS PERFORMED AND FOUND THAT THE DEVICE EXCEEDED PROJECTED LONGEVITY BY 0.29 YEAR. THE DEVICE EXHIBITED NORMAL BATTERY DEPLETION. NO ANOMALIES WERE FOUND.

    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 IMPLANTABLE CARDIAC MONITOR EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS NOTED THAT THE LOW BATTERY INDICATION WAS NO PRECEDED BY EXCESSIVE TRANSMISSION OR HIGH VOLUME OF EVENT DATA STORAGE. ON (B)(6) 2020, THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007740 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DM3500 S000057100 05415067027320

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention