BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 17527229 · Received August 12, 2023

    Report

    Report Number
    MW5134164
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    October 5, 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

    TECHNICAL SERVICES RECEIVED A CALL ON 10/05/2011 FROM SALES REP. PATIENT PRESENTED TO ER WITH LIGHTHEADEDNESS AND DIZZINESS. ATRIAL UNDERSENSING NOTED, PACING AT LOWER RATE OF 50PPM; UNDERLYING RHYTHM 2ND DEGREE AVB; ISSUE RESOLVED WITH REPROGRAMMING. KTL THE PROCEDURE TOOK PLACE AT (B)(6) HOSPITAL. THE PHYSICIAN WAS DR. (B)(6). 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
    763048 UNKNOWN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown