BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 19955497 · Received August 9, 2024

    Report

    Report Number
    2649622-2024-21170
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 9, 2024
    Manufacturer
    MPRI
    Product Code
    NVN
    UDI-DI
    00763000740269
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD. THE LV LEAD WAS EXPLANTED. AN ATTEMPT TO REPLACE THE LV LEAD WITH LEFT BUNDLE BRANCH (LBB) LEAD WAS ATTEMPTED. THE LBB LEAD EXHIBITED POSITIONING AND PLACEMENT DIFFICULTY AND DISLODGED DURING THE IMPLANT ATTEMPT. THE LBB LEAD WAS REMOVED AND A SECOND LBB LEAD WAS ATTEMPTED. THE SECOND LBB LEAD EXHIBITED POSITIONING AND PLACEMENT DIFFICULTY ALONG WITH INSERTION OR WITHDRAWAL RESISTANCE. THE SECOND LBB LEAD ALSO DISLODGED DURING THE IMPLANT ATTEMPT. THE LBB LEAD WAS REMOVED AND NO REPLACEMENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216163 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MPRI 383069 00763000740269

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention| H