BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 11595581 · Received March 31, 2021

    Report

    Report Number
    2182208-2021-01279
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    January 1, 2021
    Report Date
    March 31, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS FEMALE/76 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE TO NO AVAIL. IF NEW INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: OCCURRENCE OF PERSISTENT ATRIAL FIBRILLATION DURING PACING FOR SINUS NODE DISEASE: THE INFLUENCE OF HIS BUNDLE PACING VERSUS MANAGED VENTRICULAR PACING JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2021. 32:110-116. DOI: 10.1111/JCE.14810. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING ATRIAL FIBRILLATION (AF) DURING HIS BUNDLE PACING FOR SINUS NODE DISEASE. OF NOTE, TWO PATIENTS WERE OBSERVED WITH HIGH AND UNSTABLE PACING THRESHOLDS ON THEIR LEAD. THESE TWO LEADS WERE REPOSITIONED IN THE RIGHT VENTRICULAR (RV) SEPTUM AND REPROGRAMMED. FIVE PATIENTS PRESENTED WITH INCREASED PACING THRESHOLD WHICH NO INTERVENTION WAS COMPLETED. ONE PATIENT'S LEAD HAD DISLODGED FROM THE RV DURING THE FIRST FEW MONTHS OF FOLLOW UP AND WAS SUCCESSFULLY REPOSITIONED. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494520 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 3830

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R