BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENO

    MDR report key: 16713766 · Received April 11, 2023

    Report

    Report Number
    1000165971-2023-00286
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 11, 2023
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    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.

    Description of Event or Problem · 0

    PATIENT WAS CALLED IN REGARD OF THE FSN CRM-SAL-2023-001. AT FOLLOW UP, THE PATIENT DID NOT SHOW ANY OF THE SIGNS OF EARLY BATTERY DEPLETION (0.36KOHM). ON (B)(6) 2023, THE NEXT FOLLOW UP IS SCHEDULED ON (B)(6) 2023 AND A PACEMAKER REPLACEMENT WILL BE SCHEDULED.

    Description of Event or Problem · 0

    PATIENT WAS CALLED IN IN REGARD OF THE FSN CRM-SAL-2023-001. AT FOLLOW UP, THE PATIENT DID NOT SHOW ANY OF THE SIGNS OF EARLY BATTERY DEPLETION (0.36KOHM). ON (B)(6) 2023, THE NEXT FOLLOW UP IS SCHEDULED ON (B)(6) 2023 AND A PACEMAKER REPLACEMENT WILL BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374500 ENO IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MICROPORT CRM S.R.L. ENO SR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown