BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO XT

    MDR report key: 19579502 · Received June 20, 2024

    Report

    Report Number
    3007208829-2024-00358
    Event Type
    Death
    Date Received
    June 20, 2024
    Date of Event
    May 19, 2024
    Report Date
    June 23, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    DSH
    UDI-DI
    00869770000203
    PMA / PMN Number
    K121319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS PRESCRIBED A ZIO XT DEVICE, WHICH IS INTENDED FOR LONG-TERM CONTINUOUS MONITORING. THE ZIO XT DEVICE WAS RETURNED TO IRHYTHM ON DAY 29. THE PATIENT PASSED AWAY ON DAY 32. ON DAY 33, IRHYTHM WAS UNABLE TO POST THE FINAL REPORT BECAUSE THE REGISTRATION HAD BEEN UNINTENTIONALLY CANCELED BY THE ACCOUNT AFTER THE PATIENT PASSED AWAY. AFTER TROUBLESHOOTING AND RESTORING THE REGISTRATION, THE PATIENT¿S REPORT WAS SUCCESSFULLY POSTED ON DAY 37. NO DEVICE MALFUNCTIONS WERE OBSERVED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH. THIS REPORT IS BEING SUBMITTED WITH AN ABUNDANCE OF CAUTION DUE TO THE DELAY IN THE NOTIFICATION. THE ZIO XT DEVICE IS INTENDED FOR LONG-TERM CONTINUOUS MONITORING. THE ZIO XT MANUAL PROVIDES CONTRAINDICATIONS AND PRECAUTION STATEMENTS REGARDING THE USE OF THIS DEVICE ON A PARTICULAR GROUP OF PATIENTS. THE ¿CONTRAINDICATIONS¿ SECTION STATES, ¿ DO NOT USE THE ZIO XT PATCH FOR PATIENTS WITH SYMPTOMATIC EPISODES WHERE VARIATIONS IN CARDIAC PERFORMANCE COULD RESULT IN IMMEDIATE DANGER TO THE PATIENT.¿ IN ADDITION, THE ZIO XT MANUAL STATES IN THE ¿ PRECAUTION¿ SECTION THAT THE ¿SAFETY AND EFFECTIVENESS OF THE ZIO XT PATCH ON PATIENTS RECEIVING ANY FORM OF PACING THERAPY HAS NOT BEEN ESTABLISHED. PACED CARDIAC RHYTHMS MAY NOT BE ACCURATELY DETECTED AND MAY BE INCORRECTLY CLASSIFIED.¿ THIS EVENT IS BEING REPORTED PER 21 CFR 803 AS AN ADVERSE EVENT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY IRHYTHM THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR MALFUNCTIONED. THESE TERMS ARE INCLUDED IN FORMFDA 3500A AND ARE FIXED TERMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED IN RESPONSE TO THE FDA NOTIFICATION RECEIVED ON SEPTEMBER 26, 2024, CONCERNING MISSING UDI NUMBERS IN MDR SUBMISSIONS FROM OCTOBER 2023 THROUGH DECEMBER 2024. IN RESPONSE TO THIS ISSUE, IRHYTHM CONDUCTED AN INVESTIGATION AND IDENTIFIED A SYSTEM PROCESSING ERROR, WHICH HAS NOW BEEN RESOLVED. PLEASE SEE THE UPDATE IN SECTION D4.

    Description of Event or Problem · 0

    THE PATIENT EXPIRED AFTER THEIR PRESCRIBED ZIO XT WEAR PERIOD. THE ACCOUNT REPORTED THAT THE PATIENT¿S CAUSE OF DEATH WAS ATTRIBUTED TO VENTRICULAR TACHYCARDIA, END-STAGE RENAL DISEASE, AND MULTIPLE MYELOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654298 ZIO XT RECORDER, MAGNETIC TAPE, MEDICAL DSH IRHYTHM TECHNOLOGIES, INC 00869770000203

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death