BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURITY MRI

    MDR report key: 9153776 · Received October 3, 2019

    Report

    Report Number
    2017865-2019-14605
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    September 18, 2019
    Report Date
    January 20, 2020
    Manufacturer
    ABBOTT
    Product Code
    LWP
    UDI-DI
    05414734509602
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IN NORMAL MODE WHEN RECEIVED FOR ANALYSIS. ANALYSIS PERFORMED INCLUDING ELECTRICAL, MECHANICAL AND ENVIRONMENTAL STRESS TESTING INDICATED THE DEVICE EXHIBITED NORMAL CHARACTERISTICS. THE DEVICE DID NOT REVERT TO BACKUP VVI PROGRAMMING THROUGHOUT THE ENTIRE TESTS. LONGEVITY ASSESSMENT WAS PERFORMED, AND DEVICE WAS IN THE NORMAL RANGE OF OPERATION WITH APPROPRIATE REMAINING LONGEVITY. THE REPORTED EVENT OF BACKUP VVI WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) 2019 THE PHYSICIAN INTERROGATED THE ENDURITY DR (B)(6) SN (B)(4) IMPLANTED ON (B)(6) 2019 AND FOUND A WARNING MESSAGE REGARDING A BUP VVI REPROGRAMMING. THE TS HAS BEEN CONTACTED AND THE PACEMAKER HAS BEEN UNLOCKED AND REPROGRAMMED. THE PHYSICIAN HAS BEEN INFORMED THAT THE PACEMAKER COULD GO BACK AGAIN TO BUP VVI. SINCE IT WAS THE SECOND TIME THAT THE PACEMAKER WENT IN BUP VVI ( PER-2019-0153323), THE PHYSICIAN DECIDED TO REPLACE THE PACEMAKER NEXT MONDAY. AFTER THE REPLACEMENT, THE PACEMAKER WILL BE RETAINED BY THE HOSPITAL FOR A CERTAIN PERIOD AND THEN IT WILL BE RETURNED FOR FURTHER ANALYSIS. PATIENT'S CONDITIONS WERE GOOD AND STABLE PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE. DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS NOTED TO BE IN BACKUP MODE. TECHNICAL SUPPORT WAS CONTACTED AND RESTORED THE DEVICE SETTINGS. HOWEVER, SINCE THE DEVICE WENT INTO BACKUP MODE BEFORE, THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946708 ENDURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ABBOTT PM2172 P000070756 05414734509602

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R