BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 17531556 · Received August 12, 2023

    Report

    Report Number
    MW5138469
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    October 7, 2011
    Report Date
    November 3, 2011
    Manufacturer
    SORIN
    Product Code
    KFJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2011 DURING THIS PROCEDURE IT WAS NOTED THE DEVICE HAD A LOOSE PIN. IT WAS RECONNECTED AND PROCEDURE WAS PERFORMED SUCCESSFULLY. THIS TOOK PLACE AT (B)(6) HOSPITAL WITH 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
    1354331 UNKNOWN MATERIALS, REPAIR OR REPLACEMENT, PACEMAKER KFJ SORIN REPLY DR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown