BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 20951490 · Received December 17, 2024

    Report

    Report Number
    2182208-2024-05331
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    October 1, 2022
    Report Date
    December 17, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS 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 MALE/74 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: PREDICTORS OF LOSS OF CAPTURE IN LEFT BUNDLE BRANCH PACING: A MULTICENTER EXPERIENCE. HEART RHYTHM. 2022; 19:1757¿1758. DOI: 10.1016/J.HRTHM.2022.06.003. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING LEFT BUNDLE BRANCH PACING. THE AUTHORS DESCRIBED TWO PATIENTS WHO EXPERIENCED SEPTAL PERFORATIONS AND ONE WITH SEPTAL VEIN INJURY, BUT ALL WITHOUT HEMODYNAMIC COMPROMISE. THERE WERE LEADS WHICH EXHIBITED LOSS OF CAPTURE WHICH OCCURRED ON POSTOPERATIVE DAY ONE, WITHIN 30 DAYS OF IMPLANT, OR AFTER 30 DAYS. TWO LEADS REQUIRED REPOSITIONING: ONE DUE TO HIGH THRESHOLDS AND ONE DUE TO DISLODGMENT. THE STATUS OF THE LEADS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239691 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male UNKNOWN CIED AND LEADS