BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 20450571 · Received October 15, 2024

    Report

    Report Number
    2182208-2024-04460
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    January 1, 2024
    Report Date
    October 15, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: IMPACT OF IMMUNOSUPPRESSIVE THERAPY ON LEAD DISLODGEMENT AFTER CARDIAC IMPLANTABLE ELECTRONIC DEVICE IMPLANTATION. CLINICAL CARDIOLOGY. 2024. 47: E24310. DOI: 10.1002/CLC.24310 MEDTRONIC PRODUCTS REFERENCED: 5076 (PRODUCT CODE DTB), 5086 (PRODUCT CODE NVN), 3830 (PRODUCT CODE NVN), 6935 (PRODUCT CODE LWS), 6947 (PRODUCT CODE LWS), 4298 (PRODUCT CODE OJX), 4598 (PRODUCT CODE OJX), 4296 (PRODUCT CODE OJX), 4396 (PRODUCT CODE OJX), 4798 (PRODUCT CODE OJX). 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

    LITERATURE WAS REVIEWED REGARDING LEAD DISLODGEMENT AND IMMUNOSUPPRESSIVE THERAPY AFTER CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) IMPLANTATION. CHEST X-RAY WAS PERFORMED JUST AFTER THE PROCEDURE AND CHEST TAPE WAS USED TO RESTRAIN THE UPPER LIMB. PACEMAKER CHECK, ELECTROCARDIOGRAM, AND CHEST X-RAY WERE PERFORMED AT ONE WEEK AFTER THE PROCEDURE, ALONG WITH FOLLOW-UP OF THE WOUND. THE AUTHORS DESCRIBED DEATHS WHICH OCCURRED IN TWO PATIENTS WITHOUT IMMUNOSUPPRESSIVE THERAPY WITHIN THIRTY DAYS OF THE IMPLANT PROCEDURE; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN. THERE WAS ONE PATIENT WHO EXPERIENCED CARDIAC ARREST WITHIN TWENTY-FOUR HOURS OF THE PROCEDURE, OTHER PATIENTS THAT EXPERIENCED HEMATOMA, CARDIAC TAMPONADE, PNEUMOTHORAX, HEMOTHORAX, INFECTIONS, ALLERGY, PHRENIC NERVE STIMULATION, DYSPNEA, FATIGUE, BRADYCARDIA, OR PROLONGED HOSPITALIZATION DUE TO THE PROCEDURE. THERE WERE LEADS WHICH EXHIBITED DISLODGMENTS, SENSING FAILURE, AND PACING FAILURE WAS ALSO NOTED AND REOPERATIONS WERE REQUIRED. THE STATUS OF THE DEVICES AND LEADS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360283 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| H UNKNOWN CIED.