BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 17533811 · Received August 12, 2023

    Report

    Report Number
    MW5140714
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    December 6, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    OJX
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNICAL SERVICES RECEIVED A CALL ON 11/08/2011 FROM SALES REP. THE LEAD WAS EXOLANTED DUE TO OOCKET EROSION AND INFECTION. NO PHYSICIAN OR HOSPITAL KNOWN. 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
    1355527 MEDTRONIC DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC 4196

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown