BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPERE RF ABLATION GENERATOR

    MDR report key: 11759632 · Received May 3, 2021

    Report

    Report Number
    2184149-2021-00110
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 8, 2021
    Report Date
    August 11, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE AMPERE¿ RF ABLATION GENERATOR WAS RECEIVED INTO THE LAB FOR ANALYSIS. WHEN POWER WAS APPLIED TO THE GENERATOR, THE SCREEN ILLUMINATED RED WHILE DISPLAYING A GENERATOR MALFUNCTION ERROR, CONTACT ST. JUDE MEDICAL. THE CONTROLLER BOARD ASSEMBLY WAS TEMPORARILY REPLACED WITH A KNOWN GOOD ASSEMBLY AND UPON POWER CYCLE TO THE GENERATOR, A NORMAL BOOT UP SEQUENCE WAS OBSERVED. 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 PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, ROOT CAUSE OF THE FIELD REPORTED EVENT WAS SUCCESSFULLY ISOLATED TO ABNORMAL FUNCTIONALITY OF THE CONTROLLER BOARD ASSEMBLY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, G6, H2, H#, H6 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.

    Description of Event or Problem · 1

    DURING AN ATRIAL FLUTTER ABLATION PROCEDURE, ERROR "HIGH IMPEDANCE AT 999" APPEARED ON THE GENERATOR. DESPITE SEVERAL ATTEMPTS TO CONNECT AND RECONNECT CABLES AND CATHETER REPLACEMENT, THE ISSUE PERSISTED. THE PROCEDURE WAS UNABLE TO BE COMPLETED. THE GENERATOR WILL BE REPLACED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663719 AMPERE RF ABLATION GENERATOR EP GENERATOR OAD ST. JUDE MEDICAL H700489 5990791

    Patients

    Seq Age Sex Outcome Treatment
    1