BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPERE¿ RF ABLATION GENERATOR

    MDR report key: 16454532 · Received February 28, 2023

    Report

    Report Number
    2184149-2023-00043
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    February 15, 2023
    Report Date
    May 24, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LPB
    PMA / PMN Number
    P110016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2030404-2023-00011. DURING THE ATRIAL FIBRILLATION PROCEDURE, COMMUNICATION ISSUES WITH THE AMPERE AND THE COOL POINT PUMP RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOTED THERE WAS A "PUMP NOT CONNECTED" ERROR. THE COOL POINT PUMP WAS RECONNECTED, CABLE POWER CYCLED AND THERE WAS STILL AN ERROR. THE CASE WAS ULTIMATELY ABORTED AFTER FIVE ABLATION LESIONS, DUE TO ISSUES WITH AMPERE AND IRRIGATION PUMP. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409742 AMPERE¿ RF ABLATION GENERATOR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB ST. JUDE MEDICAL, INC. H700488

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown COOL POINT¿ IRRIGATION PUMP