BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 21992416 · Received May 9, 2025

    Report

    Report Number
    2649622-2025-12621
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    July 1, 2024
    Report Date
    May 9, 2025
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124867
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE PROXIMAL PORTION OF THE LEAD WAS RETURNED AND ANALYZED. THE ANALYSIS INDICATED THAT THE LV1/DISTAL CONDUCTOR WAS FRACTURED IN-VIVO NOT IN THE ANCHORING SLEEVE AREA. CONTINUATION OF D10: ADDRL1 IPG IMPLANTED ON (B)(6) 2013. 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

    IT WAS REPORTED THAT A FEW WEEKS AFTER THE PATIENT TORE THEIR RIGHT BICEP AND ROTATOR CUFF WHEN A RETRACTABLE AWNING COLLAPSED THAT THEY WERE SUPPORTING, THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LEAD WARNING FOR RISING AND HIGH IMPEDANCES. IT WAS ALSO NOTED THAT THE LEAD EXHIBITED A POLARITY SWITCH, HIGH THRESHOLDS, NOISE AND A CONFIRMED FRACTURE. THE LEAD WAS REPROGRAMMED WITH THE IMPLANTABLE PULSE GENERATOR (IPG) SET TO DDIR. IT WAS FURTHER NOTED THAT THE RA LEAD WAS EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR (RV) LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848578 CAPSUREFIX NOVUS LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MPRI 5076-58 00681490124867

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| H 5076-52 LEAD.