BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC LEAD

    MDR report key: 20013757 · Received August 21, 2024

    Report

    Report Number
    2182208-2024-03479
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    May 23, 2024
    Report Date
    August 17, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A VOLUNTARY MEDWATCH FORM 3500 WAS RECEIVED (REPORT #MW5156992); SINCE F10 IS NOT CONTAINED ON THAT FORM, SELECT FIELDS IN SECTION F HAVE BEEN POPULATED BY THE MANUFACTURER. F1 USER FACILITY F2 UF/IMPORTER REPORT NUMBER: F3 USER FACILITY NAME/ADDRESS F4 CONTACT PERSON: F5 PHONE NUMBER: F6 DATE USER FACILITY BECAME AWARE OF EVENT: F7 TYPE OF REPORT: (VERSION 0) F8 DATE OF THIS REPORT: 23-MAY-2024 F9 APPROXIMATE AGE OF DEVICE: F10 EVENT PROBLEM CODES: F11 REPORT SENT TO FDA: NO F12 LOCATION WHERE EVENT OCCURRED: F13 REPORT SENT TO MANUFACTURER: YES F14 MANUFACTURER NAME AND ADDRESS MFR. NAME: MEDTRONIC, PLC ADDL: 8200 CORAL SEA STREET NE CITY: MOUNDS VIEW STATE: MN ZIP: 55112. 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 LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE. THE LEAD 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
    2362437 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown