BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 19706011 · Received July 9, 2024

    Report

    Report Number
    2182208-2024-02750
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    January 1, 2024
    Report Date
    July 9, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. 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: EXTRACTION OF A DUAL-CHAMBER PACEMAKER AND SUBSEQUENT LEFT BUNDLE BRANCH AREA PACING IN A YOUNG PATIENT. ARCHIVES OF THE TURKISH SOCIETY OF CARDIOLOGY. 2024; 52(2):155-156. DOI:10.5543/TKDA.2023.30497. 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 LEFT BUNDLE BRANCH AREA PACING (LBBAP) IN A YOUNG PATIENT AFTER DEVICE EXTRACTION. THE AUTHORS DESCRIBED A PATIENT WHO WAS IMPLANTED WITH A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT HAD RECURRENT PRESYNCOPE ATTACKS AND WAS REFERRED FOR LEAD REVISIONS. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND CAPTURE FAILURE AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT LOSS OF VENTRICULAR CAPTURE. THE PATIENT'S EJECTION FRACTION HAD DECREASED, WHICH INDICATED AN APICAL PACING-INDUCED CARDIOMYOPATHY AND VENOGRAPHY PERFORMED BEFORE THE LEAD EXTRACTION PROCEDURE DEMONSTRATED OCCLUDED LEFT SUBCLAVIAN AND BRACHIOCEPHALIC VEINS. THE RA LEAD APPEARED TO HAVE A LEAD FRACTURE WITH POSSIBLE INSULATION BREAK. IT WAS SUSPECTED THAT THE RV LEAD FAILURE WAS DUE TO FIBROSIS, MICRO-DISLODGEMENT, OR MICROFRACTURE/INSULATION BREAK DUE TO CHRONIC MECHANICAL LEAD INJURY. THE PATIENT WAS SUBSEQUENTLY IMPLANTED WITH LBBAP. THE STATUS OF THE DEVICE 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
    545694 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Hospitalization| R UNKNOWN MDT IPG AND LEAD