BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHYSIQUE

    MDR report key: 12478388 · Received September 15, 2021

    Report

    Report Number
    1000165971-2021-00640
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 15, 2021
    Manufacturer
    SORIN CRM SAS
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES

    Description of Event or Problem · 1

    REPORTEDLY, THE PHYSICIAN RESPONDED TO AN URGENTLY VISITED PATIENT ON (B)(6) 2021. UPON CHECKING, NOISE WAS OBSERVED IN THE VENTRICULAR CHANNEL (SUBJECT LEAD, SCREWVINE 58SEP), AND THE PULSE WAS EXTENDED DUE TO OVERSENSING. THE PHYSICIAN JUDGED THAT THE ISSUE COULD BE ASSOCIATED TO A LEAD FAILURE. THE PATIENT HAS CAVB (COMPLETE ATRIOVENTRICULAR BLOCK) AND NO INTRINSIC RHYTHM. THE PHYSICIAN DECIDED NOT TO IMMEDIATELY PERFORM THE RE-INTERVENTION, BUT TO DECREASE THE VENTRICULAR SENSITIVITY AND FOLLOW UP. NO EVIDENCE OF THE REPORTED ISSUE WAS PROVIDED, AND THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373526 PHYSIQUE PERMANENT PACEMAKER ELECTRODE DTB SORIN CRM SAS SCREWVINE 58 SEP

    Patients

    Seq Age Sex Outcome Treatment
    1