BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 22046556 · Received May 19, 2025

    Report

    Report Number
    3004936110-2025-01032
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    May 14, 2025
    Report Date
    May 21, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE INFORMATION PROVIDED WAS PERFORMED, AND THE SENSOR WAS WITHIN THE TOLERANCE FOR CM MEAN; THEREFORE, THE REPORTED EVENT IS UNCONFIRMED. THIS REPORTED EVENT WAS INVESTIGATED FOR POSSIBLE INACCURATE READING. BASED ON A BACKEND LOG ANALYSIS, IT WAS CONFIRMED THAT THE SENSOR WAS OPERATING WITHIN THE EXPECTED FREQUENCY RANGE OF 30-37.5 MHZ. THE SENSOR WAS OPERATING AT 34.97 MHZ AND 34.93 MHZ DURING THE REVIEW OF THE APPLICABLE READING(S). A REVIEW OF THE DHR WAS PERFORMED AND EPIQ-NCMR00043966 WAS IDENTIFIED. PER ENGINEERING REVIEW, THERE WAS NO ADVERSE IMPACT TO PRODUCT OR EVIDENCE OF RELATION TO THE EVENT REPORTED. THE DATA FROM THE TEMPERATURE SENSITIVITY TEST (ASSOCIATED CS-000406 BATCH 6560580) WAS REANALYZED AND NO PHYSICAL REWORK TO THE PRODUCT OCCURRED. THERE WERE NO CHANGES TO ACCEPT AND REJECT QUANTITIES PREVIOUSLY RECORDED. ALL UNITS ARE CONFORMING TO THE CS-000406 SPECIFICATION. A LOT REVIEW WAS PERFORMED VIA COMPLAINT HANDLING SYSTEM (EPIQ) USING A SEARCH ON THE BATCH NUMBER. CONCLUSIVELY, THERE IS ONE ADDITIONAL COMPLAINT(S) RELATED TO THE ASSOCIATED BATCH, AND THE REPORTED ISSUE.

    Description of Event or Problem · 0

    A RIGHT HEART CATHETERIZATION WAS PERFORMED TO CONFIRM THE VALIDITY OF THE PRESSURE SENSOR READINGS. NO RECALIBRATION WAS NEEDED. READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132977 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL CM2000 6659568 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention