BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER EL

    MDR report key: 18275248 · Received December 5, 2023

    Report

    Report Number
    MW5148873
    Event Type
    Injury
    Date Received
    December 5, 2023
    Report Date
    October 19, 2023
    Manufacturer
    SORIN GROUP AVADA , CO/OSCOR INC.
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEAD SAFETY SWITCH (LSS) WAS TRIGGERED DUE TO LOW OUT OF RANGE PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE PATIENT HAD POCKET STIMULATION AND MYOPOTENTIAL OVERSENSING FROM THE LSS. TECHNICAL SERVICES (TS) REVIEWED THE REPORTS AND NOTED THAT THE PATIENT EXPERIENCED AN ASYSTOLE DUE TO PACING INHIBITION FOR MORE THAN 2 SECONDS. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY OTHER SYMPTOMS. TS EXPLAINED HOW TO TURN OFF LSS. THE PLAN IS TO SCHEDULE THE PATIENT FOR A DEVICE REPLACEMENT AS THE DEVICE WAS NEAR ELECTIVE REPLACEMENT INDICATOR (ERI) AND ADDRESS THE LEAD. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877017 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER EL DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER EL NVN SORIN GROUP AVADA , CO/OSCOR INC. P758

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention