BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPICARDIAL LEAD

    MDR report key: 22546917 · Received July 18, 2025

    Report

    Report Number
    2649622-2025-19635
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    February 10, 2025
    Report Date
    December 24, 2025
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00613994492302
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID W1DR01, LOT#, SERIAL# (B)(6), IMPLANTED: (B)(6) 2024, EXPLANTED: (B)(6) 2025, PRODUCT ID CMRM6133, LOT# R233674, SERIAL#, IMPLANTED: (B)(6) 2024, EXPLANTED: PRODUCT ID 4968-35, LOT#, SERIAL# (B)(6), IMPLANTED: (B)(6) 2009, EXPLANTED: 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.

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION RELATED TO CAPA (B)(4). 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 SEVEN MONTHS POST DEVICE CHANGEOUT INVOLVING AN ANTIBACTERIAL ABSORBABLE ENVELOPE, A PORTION OF THE LEAD WAS EXPOSED DUE TO THE WOUND VAC THE PATIENT HAD. THE PATIENT UNDERWENT A POCKET REVISION, AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED WITH A NEW DEVICE ON THE OTHER SIDE. THE EPICARDIAL LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400501 CAPSURE EPICARDIAL LEAD PERMANENT PACEMAKER ELECTRODE DTB MPRI 4968-35 00613994492302

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Hospitalization| R "SEE H11."