BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMEDE SYSTEM

    MDR report key: 24084709 · Received January 15, 2026

    Report

    Report Number
    3009144177-2026-00007
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    November 21, 2024
    Report Date
    January 15, 2026
    Manufacturer
    REMEDE SYSTEM
    Product Code
    PSR
    UDI-DI
    00857688007391
    PMA / PMN Number
    P160039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A FORM IS AN IDENTICAL COPY OF FAILED 3500A FORM SUBMISSION, REPORT NUMBER: 3009144-2024-00011 ORIGINALLY SUBMITTED ON 17DEC2024. THE ORIGINAL 3500A FORM FAILED AT ACK3 DUE TO THE FOLLOWING ERROR: ONLY ONE PMA/510(K) IS ALLOWED PER REPORT. THIS ERROR HAS BEEN CORRECTED. A CAPA WAS OPENED TO PREVENT REOCCURRENCE OF THE FAILED SUBMISSION.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A REMEDE SYSTEM ON (B)(6) 2024. ON (B)(6) 2024, PATIENT HAD SUCCESSFUL THERAPY ACTIVATION. ON (B)(6) 2024, PATIENT WAS EVALUATED IN THE OFFICE BY (B)(6), FNP FOR THERAPY CHANGES. AVAILABLE NOTES DO NOT MENTION ANY POSSIBLE INFECTION. ON (B)(6) 2024, PATIENT PRESENTED VIRTUALLY TO THE IMPLANT CENTER WITH A SWOLLEN AND SOMEWHAT RED POCKET. PATIENT WAS SCHEDULED FOR AN APPOINTMENT ON (B)(6) 2024. ON (B)(6) 2024, PATIENT HAD BLOODWORK AND THE REMEDE SYSTEM REMOVED DUE TO SUSPECTED POCKET INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140747 REMEDE SYSTEM IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRAL SLEEP APNEA PSR REMEDE SYSTEM 1100 00857688007391

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention