BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURE XT DR MRI SURESCAN

    MDR report key: 10298578 · Received July 20, 2020

    Report

    Report Number
    3004209178-2020-12470
    Event Type
    Injury
    Date Received
    July 20, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 20, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00643169634589
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 5076-45, LEAD, IMPLANTED: (B)(6) 2020. EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE REPLACEMENT PROCEDURE DUE TO NORMAL BATTERY DEPLETION, THE REPLACEMENT DEVICE WAS PROGRAMMED DOO, BOTH LEADS WERE PROGRAMMED BIPOLAR, LEAD MONITOR WAS PROGRAMMED TO "MONITOR", AND IMPLANT DETECT WAS PROGRAMMED ON. WHILE THE DEVICE REMAINED OUTSIDE THE POCKET, THE PHYSICIAN CONNECTED THE NEW ATRIAL LEAD FIRST, FOLLOWED BY THE RIGHT VENTRICULAR (RV) PORTION OF THE CHRONIC VDD-TYPE RV LEAD. THE DEVICE PACED THE RV FOR 23 BEATS, DROPPED ONE BEAT, PACED FOR 8 ADDITIONAL BEATS, DROPPED ONE BEAT, PACED FOR 4 ADDITIONAL BEATS, DROPPED ONE BEAT, THEN PACED FOR 3 ADDITIONAL BEATS, WHEREUPON THE PATIENT EXPERIENCED ASYSTOLE FOR ABOUT 30 SECONDS, DURING WHICH TIME IT WAS REALIZED THAT ASYSTOLE WAS ACTUALLY OCCURRING. AT THIS POINT, THE PHYSICIAN DISCONNECTED THE RV LEAD AND IT WAS RE-INSERTED INTO THE OLD DEVICE, WHICH RESTORED PACING. THE RV LEAD WAS THEN TESTED THROUGH THE ANALYZER, WITH NO INCONSISTENCIES SEEN. THE PHYSICIAN REQUESTED A NEW DEVICE, WHICH WAS THEN PROGRAMMED THE SAME AS THE FIRST ATTEMPTED REPLACEMENT, BUT THIS TIME THE RV LEAD WAS CONNECTED FIRST, WITH NO PROBLEMS ENCOUNTERED. LEAD PIN VISUALIZATIONS AND TUG TESTS HAD BEEN PERFORMED ON BOTH DEVICES. THE SECOND REPLACEMENT DEVICE WAS IMPLANTED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762268 AZURE XT DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. W1DR01 00643169634589

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening