BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 18527000 · Received January 17, 2024

    Report

    Report Number
    3004936110-2024-00117
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 15, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Removal / Correction Number
    FA-Q323-HF-4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FA-Q323-HF-4 CARDIOMEMS PES RIGHT ANGLE POWER EXTENSION CABLE FAILURE NOTICE ISSUED BY ABBOTT ON (B)(6) 2023. THE INVESTIGATION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Additional Manufacturer Narrative · 0

    EXTERNAL VISUAL INSPECTION OF RETURNED MATERIAL REVEALED PHYSICAL DAMAGE TO RIGHT ANG EXT CABLE. DURING THE INVESTIGATION, VISUAL INSPECTION REVEALED THAT THE POWER EXTENSION CONNECTOR WAS SEATED IN THE CONNECTOR COVER. NO SOFTWARE MALFUNCTIONS OR ANOMALIES WERE OBSERVED. A GOLDEN RIGHT ANG EXT CABLE WAS USED FOR PERFORMANCE TESTING DUE TO DAMAGE TO THE ONE RETURNED. THE UNIT POWERED ON SUCCESSFULLY IN CONJUNCTION WITH GOLDEN RIGHT ANG EXT CABLE WITH THE POWER SUPPLY CONNECTED DIRECTLY TO IT. PATIENT DATA BACK-UP PERFORMED WITHOUT ERRORS USING RETURNED GSM MODEM. UNIT PASSED DIAGNOSTIC TEST. COMPLAINT OF ¿THE UNIT WOULD NOT POWER ON¿ CONFIRMED. UNIT DETERMINED TO HAVE POWER MALFUNCTION DUE TO DAMAGE TO RIGHT ANG EXT CABLE. A REVIEW OF THE DHR WAS PERFORMED FOR BATCH #8050652 AND RULED OUT THE POSSIBILITY OF A MANUFACTURING RELATED ISSUE CAUSING OR CONTRIBUTING TO THE REPORTED COMPLAINT ISSUE, AS NO NON-CONFORMANCE RELATED TO THE REPORTED ISSUE WAS FOUND IN THE BATCH RECORDS REVIEWED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED EXPOSED WIRES OF THE POWER CONNECTOR PLUG. THE PATIENT ELECTRONIC UNIT WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602070 CARDIOMEMS PATIENT ELECTRONIC SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM1100 8050652 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female