BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19513088 · Received June 10, 2024

    Report

    Report Number
    MW5156134
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Report Date
    April 23, 2024
    Manufacturer
    ST. JUDE MEDICAL / ABBOTT MEDICAL
    Product Code
    MVM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TECHNICAL SERVICES (TS) WAS CONTACTED BY THE HEALTH CARE PROFESSIONAL (HCP) FOR INSTRUCTIONS ON PROGRAMMING THE PACEMAKER TO MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE. TS INSTRUCTED THE HCP ON PROGRAMMING MRI PROTECTION MODE. THE RIGHT ATRIAL (RA) AND THIS RIGHT VENTRICULAR (RV) LEADS WERE NOT MRI CONDITIONAL LEADS. NO 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
    766297 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE MVM ST. JUDE MEDICAL / ABBOTT MEDICAL 2088TC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown