BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 17521013 · Received August 12, 2023

    Report

    Report Number
    MW5127961
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    October 11, 2011
    Report Date
    November 3, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS RA LEAD WAS IMPLANTED ON (B)(6) 1999. A CALL TO TECHNICAL SERVICES ON 10/11/2011 STATES THAT THERE HAS BEEN A RISE IN ATRIAL IMPEDANCE. RA IMPEDANCES RISING SINCE 1 YEAR AGO AND THEN DROPPED BACK DOWN TO 300'S. (B)(6) 2010-844 AND IN (B)(6) 2010-400'S, (B)(6) 2010- 968 AND TODAY 1169. THRESHOLDS VARY A LITTLE BIT BUT NOT OUT OF RANGE SENSING IS GOOD. CALLER STATED THAT SHE WILL CALL MEDTRONIC FOR RANGE ON THIS LEAD. 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
    2176877 UNKNOWN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 6940

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown