BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 17520211 · Received August 12, 2023

    Report

    Report Number
    MW5127159
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    October 25, 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 10/25/2011 FROM SALES REP. REP DID A CHANGEOUT ON PATIENT WITH MDT DEVICE AND 2 MDT LEADS. LEADS WERE BOTH FOUND TO BE DAMAGED. REP NOTED THEY WERE BOTH FOUND TO HAVE INSULATION PROBLEMS AROUND THE POCKET AREA. 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
    2219286 UNKNOWN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown