BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17525258 · Received August 12, 2023

    Report

    Report Number
    MW5132199
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    March 21, 2018
    Report Date
    July 10, 2018
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS RV LEAD WAS IMPLANTED ON (B)(6) 2007 AND REMAINS IMPLANTED AS OF THE PRESENT. A CALL PLACED TO TECHNICAL SERVICES ON 04/12/2018 STATING THAT HIS LEAD HAD AN OUT OF RANGE IMPEDANCE GREATER THAN 2000 OHMS ON (B)(6) 2018 AND (B)(6) 2018. THE IMPEDANCE ISSUE HAD TRIPPED LEAD SAFETY SWITCH. ALSO, THERE WERE MULTIPLE ALERTS OF VENTRICULAR TACHYCARDIA EPISODES THAT SHOWED NOISE TYPICAL OF UNIPOLAR PROGRAMMING. THE FOLLOWING PHYSICIAN WAS DR. YERRA LAKSHMINARAYAN AT NHI - KEARNEY IN KEARNEY, NE. NO OTHER INFORMATION IS AVAILABLE. 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
    2234291 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown