BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENO

    MDR report key: 19665560 · Received July 3, 2024

    Report

    Report Number
    1000165971-2024-00542
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    May 30, 2024
    Report Date
    August 29, 2024
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE CONCLUSIONS ARE AS FOLLOWS: THE ELECTRICAL CHARACTERISTICS OF THE RETURNED DEVICE CONFORMED TO ESTABLISHED SPECIFICATIONS. UPON RECEPTION OF THE DEVICE, PACING PULSES WERE GENERATED APPROPRIATELY BY THE DEVICE. THE VISUAL INSPECTION DID NOT REVEAL ANY ABNORMALITY. THE ANALYSIS CONFIRMS THAT THE CONNECTION SYSTEM OF THE SUBJECT PACEMAKER FUNCTIONED AS SPECIFIED USING A DUPLICATE TORQUE-LIMITING SCREWDRIVER. THE ISSUE HAS NOT BEEN REPRODUCED. PRESENCE OF BLOOD WAS OBSERVED INSIDE THE VENTRICULAR CONNECTOR. THIS BLOOD INFILTRATION MAY HAVE BEEN INCURRED THROUGH REPETITIVE INSERTION AND REMOVAL OF THE ASSOCIATED SCREWDRIVER. BASED ON THE AVAILABLE DATA, THE MOST LIKELY HYPOTHESIS WOULD BE A LEAD CONNECTION ISSUE INDUCING ELECTRICAL ISSUE AFTER A WHILE (CONNECTION DEFINITIVELY LOST). - THIS COMPLAINT HAS BEEN RECORDED FOR TRENDING PURPOSES. FOR MORE DETAILS, PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 0

    THIS PACEMAKER IMPLANTED ON (B)(6) 2024 AND EXPLANTED ON (B)(6) 2024 DUE TO A MALFUNCTION OF THE VENTRICULAR LEAD. PATIENT BRADYCARDIC, VENTRICULAR LEAD IMPEDANCE >3000 OHMS, NO MORE PACING. DURING THE EXPLANTATION, THE VENTRICULAR LEAD WENT OUF THE CONNECTOR WITHOUT LOOSENING. THIS LEAD HAS BEEN TESTED WITH PSA AND EVERYTHING WAS CORRECT. NO LEAD REPLACEMENT WAS NEEDED, ONLY THE PACEMAKER HAS BEEN REPLACED. CHEST X-RAY: NO LEAD FRACTURE.

    Description of Event or Problem · 0

    THIS PACEMAKER IMPLANTED ON (B)(6) 2024 AND EXPLANTED ON (B)(6) 2024 DUE TO A MALFUNCTION OF THE VENTRICULAR LEAD. PATIENT BRADYCARDIC, VENTRICULAR LEAD IMPEDANCE >3000 OHMS, NO MORE PACING. DURING THE EXPLANTATION, THE VENTRICULAR LEAD WENT OUF THE CONNECTOR WITHOUT LOOSENING. THIS LEAD HAS BEEN TESTED WITH PSA AND EVERYTHING WAS CORRECT. NO LEAD REPLACEMENT WAS NEEDED, ONLY THE PACEMAKER HAS BEEN REPLACED. CHEST X-RAY: NO LEAD FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801248 ENO IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MICROPORT CRM S.R.L. ENO DR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown