BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 20539489 · Received October 25, 2024

    Report

    Report Number
    2182208-2024-04592
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    May 2, 2023
    Report Date
    October 25, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    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. 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 BASELINE GENDER/AGE CHARACTERISTICS IS MALE/71 YEARS OLD. 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: LOW UTILIZATION OF LEAD EXTRACTION AMONG PATIENTS WITH INFECTIVE ENDOCARDITIS AND IMPLANTED CARDIAC ELECTRONIC DEVICES. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. 2023; 81:1714¿1725. DOI: 10.1016/J.JACC.2023.02.042. 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 TRANSVENOUS LEAD REMOVAL/EXTRACTION (TLE) AMONG PATIENTS WITH CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICES (CIEDS) AND INFECTIVE ENDOCARDITIS. PATIENTS WERE ADMITTED WITH ENDOCARDITIS AND WERE MANAGED WITH TLE OR WITHOUT AND WERE TREATED WITH ANTIMICROBIAL THERAPY. THERE WERE PATIENTS WITH CONCOMITANT STAPHYLOCOCCUS AUREUS INFECTIONS. THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN. SOME OF THE DEATHS OCCURRED IN THE INDEX HOSPITALIZATION FOR ENDOCARDITIS AND OTHER DEATHS OCCURRED WITHIN 30 DAYS OF THE READMISSION FOR TLE. AMONG PATIENTS MANAGED WITH TLE, PROCEDURAL COMPLICATIONS INCLUDED SUPERIOR VENA CAVA INJURY/INNOMINATE VEIN INJURY/OTHER VASCULAR COMPLICATIONS, CARDIAC PERFORATION/TAMPONADE, AND PNEUMOTHORAX/HEMOTHORAX. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819171 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Life Threatening| R| H UNKNOWN COMPETITOR CIED.