BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE CS/SVC LEAD

    MDR report key: 22408483 · Received July 6, 2025

    Report

    Report Number
    2649622-2025-18146
    Event Type
    Injury
    Date Received
    July 6, 2025
    Date of Event
    June 12, 2025
    Report Date
    July 6, 2025
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00643169536029
    PMA / PMN Number
    P980050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0673 LEAD IMPLANTED (B)(6) 2022. 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 THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED POST POCKET CLOSURE ON THE DAY OF IMPLANT. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2767919 TRANSVENE CS/SVC LEAD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MPRI 6937A-52 00643169536029

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Hospitalization| R DVPA2D4 ICD, 5019 ADAPTOR