BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 17830993 · Received September 28, 2023

    Report

    Report Number
    3007208829-2023-00053
    Event Type
    Death
    Date Received
    September 28, 2023
    Date of Event
    August 20, 2023
    Report Date
    November 30, 2023
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    DSI
    PMA / PMN Number
    K163512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PREVIOUSLY REPORTED INVESTIGATION FINDINGS AND CODES BASED ON AN ADDITIONAL REVIEW OF THE COMPLAINT. A REVIEW OF THIS COMPLAINT DISCOVERED THAT THE PATIENT WAS PRESCRIBED A ZIO AT DEVICE THAT WAS PLACED IN CLINIC BY THEIR PHYSICIAN. ON DAY 3 IRHYTHM CALLED THE PATIENT TO FOLLOW UP ON THE ¿NO CONNECTION 24 HOURS¿ STATUS, THE PATIENT STATED HE WAS IN A REMOTE AREA AND WOULD BE FOR 2 - 3 WEEKS, BUT HE WOULD TRAVEL INTO BETTER SERVICE AREAS FROM TIME TO TIME. DURING THE CALL, IRHYTHM CUSTOMER CARE PERFORMED TROUBLESHOOTING OF THE ZIO DEVICE AND CONFIRMED THAT THE DEVICE WOULD TRANSMIT IN A BETTER SERVICE AREA. THERE WERE NO KNOWN ZIO PATCH ISSUES AT THAT TIME. THE ZIO AT WAS RETURNED TO IRHYTHM FOR EVALUATION. AVAILABLE DEVICE DATA INDICATES THAT THE PATCH WAS REMOVED FROM THE PATIENT ON DAY 11. THERE WERE ACTIONABLE ARRHYTHMIAS IDENTIFIED THAT DID NOT MEET AUTO-DETECTION CRITERIA DURING DAY 6. THE END-OF-LIFE EVENT OCCURRED ON DAY 10 AND DID NOT TRANSMIT DUE TO THE CELLULAR CONNECTIVITY ISSUE. THE EVENTS WERE FOUND WHILE PREPARING THE FINAL REPORT. THE INVESTIGATION DID NOT FIND EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. HOWEVER, DID CONFIRM THE REPORTED CONNECTION ISSUE, AS A CONNECTION GAP WAS NOTED FROM DAY 2 THROUGH DAY 6 DURING THE PATIENT¿S WEAR PERIOD. ADDITIONALLY, A BLUETOOTH ERROR WAS ALSO NOTED ON DAY 5, THE ERROR WAS NOT DETECTED AT THE TIME OF WEAR BECAUSE THE PATIENT WAS IN AN AREA THAT DID NOT HAVE CELLULAR CONNECTION. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY IRHYTHM THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED. CERTAIN TERMS INCLUDED IN FORM FDA 3500A AND RELATED MDR SUBMISSION MATERIALS 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

    A REVIEW OF THIS COMPLAINT DISCOVERED THAT THE PATIENT WAS PRESCRIBED A ZIO AT DEVICE THAT WAS PLACED IN CLINIC BY THEIR PHYSICIAN. ON DAY 3 IRHYTHM CALLED THE PATIENT TO FOLLOW UP ON THE ¿NO CONNECTION 24 HOURS¿ STATUS, THE PATIENT STATED HE WAS IN A REMOTE AREA AND WOULD BE FOR 2 - 3 WEEKS, BUT HE WOULD TRAVEL INTO BETTER SERVICE AREAS FROM TIME TO TIME. DURING THE CALL, IRHYTHM CUSTOMER CARE PERFORMED TROUBLESHOOTING OF THE ZIO DEVICE AND CONFIRMED THAT THE DEVICE WOULD TRANSMIT IN A BETTER SERVICE AREA. THERE WERE NO KNOWN ZIO PATCH ISSUES AT THAT TIME. THE ZIO AT WAS RETURNED TO IRHYTHM FOR EVALUATION. AVAILABLE DEVICE DATA INDICATES THAT THE PATCH WAS REMOVED FROM THE PATIENT ON DAY 11. THERE WERE ACTIONABLE ARRHYTHMIAS IDENTIFIED THAT DID NOT MEET AUTO-DETECTION CRITERIA DURING DAY 6. THE END-OF-LIFE EVENT OCCURRED ON DAY 10 AND DID NOT TRANSMIT DUE TO THE CELLULAR CONNECTIVITY ISSUE. THE EVENTS WERE FOUND WHILE PREPARING THE FINAL REPORT. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION DID NOT FIND EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH, AS IT FUNCTIONED AS INTENDED. HOWEVER, DID CONFIRM THE REPORTED CONNECTION ISSUE, AS A CONNECTION GAP WAS NOTED FROM DAY 2 THROUGH DAY 6 DURING THE PATIENT¿S WEAR PERIOD. THERE WERE NO ARRHYTHMIAS NOTED THAT MET DETECTION DURING THIS TIME. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY IRHYTHM THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED. CERTAIN TERMS INCLUDED IN FORM FDA 3500A AND RELATED MDR SUBMISSION MATERIALS ARE FIXED TERMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING.

    Description of Event or Problem · 0

    THE PATIENT EXPIRED DURING THEIR PRESCRIBED ZIO AT WEAR PERIOD. IRHYTHM ATTEMPTED TO GATHER MORE INFORMATION ABOUT THE CAUSE OF DEATH FROM THE ACCOUNT, BUT NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847264 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death