BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEIR LEADLESS PACEMAKER

    MDR report key: 12130277 · Received July 6, 2021

    Report

    Report Number
    MW5102320
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 1, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PNJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5102320 ON 08/08/2022 TO ADD PROCODE PNJ.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO SCREW IN THE DEVICE WITH SLOW INCREMENTAL CLOCKWISE ROTATION RESULTED IN THE SHAFT OF THE CATHETER DEPLOYMENT FLIPPING AXIS AS THE TORQUE APPEARED TO TRANSMIT TO THE SHAFT AS OPPOSED TO ONLY TO THE LEADLESS PACEMAKER. ATTEMPTING TO UNDO THE TORQUE ON THE SHAFT WAS DIFFICULT. IT WAS THEREFORE DECIDED TO UNSCREW THE DEVICE AND ATTEMPT REDEPLOYMENT. HOWEVER WE NOTICED THAT THE SCREW MECHANISM ON THE TIP OF THE LEADLESS PACEMAKER APPEARED TO UNFURL, AND IT WAS DECIDED TO CHANGE OUT THE WHOLE SYSTEM FOR A NEW DEVICE AND SHEATH. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021035 AVEIR LEADLESS PACEMAKER LEADLESS PACEMAKER PNJ ABBOTT MEDICAL LSP112V
    1021036 AVEIR LEADLESS PACEMAKER LEADLESS PACEMAKER PNJ ABBOTT MEDICAL LSP112V

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Other