BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENO

    MDR report key: 17216129 · Received June 28, 2023

    Report

    Report Number
    1000165971-2023-00485
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    May 26, 2023
    Report Date
    September 12, 2023
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11. CORRECTED DATA: D2. TYPE OF DEVICE CHANGED TO LWP - IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT), SINCE LWS WAS CHOSEN BY MISTAKE AT INITIAL REPORT. G3.3. DATE RECEIVED BY MANUFACTURER CHANGED TO 31/08/2023 AS R&D ANALYSIS RESULTS RECEIVED.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES. PRELIMINARY INVESTIGATION LED TO THE FOLLOWING CONCLUSION: THE VENTRICULAR LEAD (NON MICROPORT CRM PRODUCT) MOST LIKELY IS FRACTURED AND NEEDS TO BE REPLACED. VENTRICULAR OVERSENSING , HIGH VENTRICULAR IMPEDANCE , VENTRICULAR BURSTS SHOWING ARTEFACTS CHARACTERISTIC FOR LEAD FRACTURE, IN ADDITION HIGH FREQUENCY NOISE OVERSENSING WAS OBSERVED THAT MIGHT BE RELATED TO THE SUSPECTED LEAD FRACTURE BUT NEEDS FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    REPORTEDLY, NOISE OVERSENSING WAS DETECTED ON THE VENTRICULAR LEAD DURING DEVICE FOLLOW UP. FURTHER INVESTIGATION AND ARM MANIPULATION REPRODUCED FURTHER VENTRICULAR OVERSENSING.

    Description of Event or Problem · 0

    REPORTEDLY, NOISE OVERSENSING WAS DETECTED ON THE VENTRICULAR LEAD DURING DEVICE FOLLOW UP. FURTHER INVESTIGATION AND ARM MANIPULATION REPRODUCED FURTHER VENTRICULAR OVERSENSING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231666 ENO IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MICROPORT CRM S.R.L. ENO SR
    1782919 ENO IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MICROPORT CRM S.R.L. ENO SR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown