BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYO/WIRE

    MDR report key: 24688186 · Received March 25, 2026

    Report

    Report Number
    MW5185817
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    March 9, 2026
    Report Date
    March 19, 2026
    Manufacturer
    A&E MEDICAL CORP./ALTO DEVELOPMENT CORP.
    Product Code
    IKD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2026, A POST¿AORTIC VALVE REPLACEMENT PATIENT WHO WAS TEMPORARILY DEPENDENT ON EPICARDIAL PACING EXPERIENCED A SYNCOPAL EPISODE DUE TO A FRACTURED TEMPORARY PACEMAKER WIRE. THE PATIENT REGAINED CONSCIOUSNESS SPONTANEOUSLY AND RECEIVED SUPPORTIVE CARE WHILE BEING PREPARED FOR TRANSFER TO THE CARDIAC CATHETERIZATION LAB, WHERE A REPLACEMENT TEMPORARY PACING SYSTEM WAS PLACED. NO FURTHER COMPLICATIONS WERE REPORTED FOLLOWING THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745008 MYO/WIRE TEMPORARY PACING WIRE IKD A&E MEDICAL CORP./ALTO DEVELOPMENT CORP. 019-530 30085

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention