BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC LEAD

    MDR report key: 19691487 · Received July 8, 2024

    Report

    Report Number
    2182208-2024-02734
    Event Type
    Death
    Date Received
    July 8, 2024
    Date of Event
    October 16, 2023
    Report Date
    July 8, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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 FEMALE/57 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. 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: PROPHYLACTIC EPICARDIAL PACEMAKER IMPLANTATION IN TRICUSPID VALVE REPLACEMENT. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY. 2023, 64(6), EZAD344. DOI: 10.1093/EJCTS/EZAD344. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING PROPHYLACTIC EPICARDIAL PACEMAKER IMPLANTATION IN TRICUSPID VALVE REPLACEMENT. THE AUTHORS DESCRIBED ONE PATIENT THAT EXPERIENCED CARDIAC ARREST DUE TO VENTRICULAR TACHYCARDIA (VT) WHICH WAS SUSPECTED TO HAVE BEEN TRIGGERED BY AN INAPPROPRIATE VENTRICULAR PACE (VP) WHICH FOLLOWED A VENTRICULAR UNDERSENSING. THE PATIENT WAS IMMEDIATELY RESUSCITATED, BUT THE PATIENT DIED THREE DAYS LATER. THERE WERE OTHER PATIENT DEATHS IN THE POSTOPERATIVE PERIOD AND SOME AFTER DISCHARGE; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN. THERE WERE PATIENTS WHO EXPERIENCED HOSPITALIZATIONS FOR CONGESTIVE HEART FAILURE, ATRIAL ARRHYTHMIAS, INFECTIVE ENDOCARDITIS, AND STROKE. ONE PATIENT HAD A POCKET INFECTION AND HAD THEIR SYSTEM EXTRACTED. THERE WERE LEADS WHICH EXHIBITED LEAD DYSFUNCTIONS IN WHICH 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
    143243 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Death UNKNOWN MEDTRONIC IPG