BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17518190 · Received August 12, 2023

    Report

    Report Number
    MW5125138
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    August 10, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MEDICAL RECORDS WAS NOTIFIED ON 7/23/2012 THAT THIS RV LEAD WAS REMOVED DUE TO INFECTION ON APPROXIMATELY (B)(6) 2012. LEAD WAS IMPLANTED (B)(6) 2004. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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
    2117566 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown