BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD SERVICE KIT

    MDR report key: 17525799 · Received August 12, 2023

    Report

    Report Number
    MW5132740
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    September 1, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    KFJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A CALL TO TECHNICAL SERVICES ON (B)(6) 2011 STATES THAT DURING A DEVICE CHANGEOUT THE PHYSICIAN BROKE 10 MEDTRONIC 5873W WRENCHES ATTEMPTING TO LOOSEN THE SET SCREWS ON A DEVICE. THE 11TH WRENCH WORKED FINE. THE TIP OF THE WRENCH DID NOT BREAK OFF IN THE SCREW. THEY LITERALLY JUST BROKE APART. 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
    564024 LEAD SERVICE KIT MATERIALS, REPAIR OR REPLACEMENT, PACEMAKER KFJ MEDTRONIC 5873W

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown