BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 17519241 · Received August 12, 2023

    Report

    Report Number
    MW5126189
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    December 6, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO TECHNICAL SERVICES ON 11/7/11 THAT THIS RA LEAD HAS "LABILE" IMPEDANCES IN THE RANGE OF 500-1800 OVER SEVERAL MONTHS; THRESHOLD IS ELEVATED AT 2.9 VAT 1 MS. LESS THAN ONE PERCENT PACED. NO PLAN TO DO ANY INTERVENTION. THEY CHECKED THIS AT DR. (B)(6). CHANQED 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
    2182071 MEDTRONIC PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown