BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 22903380 · Received August 27, 2025

    Report

    Report Number
    9614453-2025-03402
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    June 25, 2025
    Report Date
    September 5, 2025
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    DSI
    UDI-DI
    00763000562625
    PMA / PMN Number
    K132649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DAILY WIRELESS AUDIT (DWA) WITH THE REMOTE MONITOR WAS MISSING FOR THE IMPLANTABLE CARDIAC MONITOR DUE TO POOR TELEMETRY. THE MONITOR SETUP WAS REVIEWED AND VERIFIED THAT THE MONITOR WAS 4 TO 6 INCHES BELOW THE MATTRESS. IT WAS SUGGESTED TO USE BOOKS TO PROP UP THE MONITOR TO THE SAME LEVEL AS THE BED AND A POSSIBLE IMPACT ON SLEEPING HABITS FOLLOWING BACK SURGERY WAS NOTED. THE PATIENT MANAGEMENT DATABASE CONFIRMED THAT THE REMOTE MONITOR SENT A SUCCESSFUL DWA TRANSMISSION SINCE THE DATE OF THE CALL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380541 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC EUROPE SARL LNQ11 00763000562625

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male