BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 20080529 · Received August 27, 2024

    Report

    Report Number
    2182208-2024-03669
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    April 22, 2024
    Report Date
    August 27, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 BASELINE GENDER/AGE CHARACTERISTICS IS MALE/82 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: PACING USING CARDIAC IMPLANTABLE ELECTRIC DEVICE DURING TAVR 10-YEAR EXPERIENCE OF A HIGH-VOLUME CENTER. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY: CARDIOVASCULAR INTERVENTIONS. 2024; 17:1020¿1028. DOI: 10.1016/J.JCIN.2024.02.028 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 PERMANENT LEAD DYSFUNCTION DURING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURES. THE AUTHORS DESCRIBED LEADS WHICH EXHIBITED PROCEDURAL DISLOCATIONS AND INCREASES IN THRESHOLDS, EXIT BLOCK, DIMINISHED SENSING, OR LOSS OF CAPTURE. ONE PATIENT WITH EXIT BLOCK REQUIRED ONE MINUTE OF CARDIOPULMONARY RESUSCITATION. THE LEADS WERE REPROGRAMMED OR REQUIRED SURGICAL REVISIONS. THE STATUS OF THE 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
    1493769 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention| H