BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS LEAD

    MDR report key: 21443725 · Received February 24, 2025

    Report

    Report Number
    2649622-2025-05186
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    February 11, 2025
    Report Date
    February 24, 2025
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490110655
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 3222 LEAD IMPLANT DATE (B)(6) 2021 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 DURING A IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE, THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO EXHIBIT INSULATION DAMAGE. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611912 CAPSURE SP NOVUS LEAD PERMANENT PACEMAKER ELECTRODE DTB MPRI 4092-52 00681490110655

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| R 1258T LEAD.