BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURITY MRI

    MDR report key: 8621155 · Received May 17, 2019

    Report

    Report Number
    2938836-2019-03867
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 17, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    DXY
    UDI-DI
    05414734509589
    PMA / PMN Number
    P140033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, THE DEVICE WAS CONNECTED TO THE LEADS. RF ANTENNA WAS UNABLE TO FIND THE DEVICE. AS THE POCKET WAS STILL OPEN, STERILE SLEEVE WAS USED TO PLACE WAND OVER THE DEVICE, BUT DEVICE WAS NOT FOUND. DURING INTERROGATION IT WAS LATER FOUND THAT THE DEVICE WAS IN BACK UP VVI MODE. THE DEVICE WAS RESTORED, AND THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415132 ASSURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PM2272 A000076793 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1