BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS POWER SUPPLY

    MDR report key: 18510974 · Received January 15, 2024

    Report

    Report Number
    3004936110-2023-01896
    Event Type
    Malfunction
    Date Received
    January 15, 2024
    Date of Event
    December 21, 2023
    Report Date
    May 13, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM POWER SUPPLY WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE POWER SUPPLY WAS FRAYED AND WIRES WERE EXPOSED. SOFTWARE EVALUATION WAS NOT POSSIBLE WITH MATERIAL RETURNED. WHEN THE RETURNED POWER SUPPLY (CC-002403) WAS PLUGGED INTO AN OUTLET VIA THE RETURNED POWER CORD (CC-002367), IT WOULD INTERMITTENTLY CUT OFF AND ON WHEN IT WAS MANIPULATED. THIS MALFUNCTION WAS ATTRIBUTED TO 'EXPOSED WIRES' IN THE POWER SUPPLY (CC-002403). A GOLDEN I3 UNIT WAS POWERED ON SUCCESSFULLY MULTIPLE TIMES IN CONJUNCTION WITH THE TEST POWER SUPPLY (CC-002403) AND RETURNED POWER CORD (CC-002367).

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO NON-CONFORMANCES WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED EVENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE PATIENT REPORTED FRAYED WIRES AND SPARKING OF THE POWER SUPPLY BOX. THE POWER SUPPLY BOX WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887732 CARDIOMEMS POWER SUPPLY SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM1110

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown