BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIFIX EZ

    MDR report key: 8581494 · Received May 6, 2019

    Report

    Report Number
    2124215-2019-08776
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    March 27, 2019
    Report Date
    July 7, 2019
    Manufacturer
    INTERMEDICS (GDT)
    Product Code
    LWS
    PMA / PMN Number
    K922972/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE REPORT WILL BE UPDATED AT THAT TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT LEAD DAMAGE OCCURRED WHEN IT WAS REMOVED FROM THE EXISTING DEVICE. AT THAT TIME THE TERMINAL PIN BECAME SEPARATED FROM THE LEAD ITSELF. THE PHYSICIAN OPTED TO MAINTAIN THE USE OF THE LEAD DESPITE THE SUBOPTIMAL MEASUREMENTS AND WILL CONTINUE TO MONITOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE REPORT WILL BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS FOR THE RIGHT ATRIAL (RA) LEAD. FURTHER REVIEW ALSO FOUND OVERSENSING OF NOISE LEADING TO INAPPROPRIATELY STORED ATRIAL TACHY RESPONSE (ATR) EPISODES SINCE THE LEAD WAS PROGRAMMED TO UNIPOLAR CONFIGURATION. IT WAS NOTED THAT DURING THE ROUTINE DEVICE REPLACEMENT PROCEDURE THE PREVIOUS DAY, THE PHYSICIAN DAMAGED THE RA LEAD WHEN DISCONNECTING IT FROM THE PREVIOUS PACEMAKER. THE PHYSICIAN OPTED TO CONTINUE TO USE THE LEAD AND INSERTED IT INTO THE ATRIAL PORT ON THE NEW PACEMAKER. IT WAS UNKNOWN THE EXTENT OF THE DAMAGE TO THE LEAD, BUT THE IMPEDANCE IN THE DEVICE CHANGE OUT PROCEDURE WAS 202 OHMS. THE CLINICIAN STATED SHE WOULD DISCUSS OPTIONS WITH THE PHYSICIAN. THE FIELD REPRESENTATIVE IS ATTEMPTING TO OBTAIN FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374616 CARDIFIX EZ IMPLANTABLE LEAD LWS INTERMEDICS (GDT) 438-05 02181MB

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR