BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC IPG

    MDR report key: 22521581 · Received July 16, 2025

    Report

    Report Number
    2182208-2025-03479
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    June 1, 2025
    Report Date
    July 16, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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/73 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: CONDUCTION SYSTEM PACING COMPARED WITH BIVENTRICULAR PACING FOR CARDIAC RESYNCHRONIZATION THERAPY IN PATIENTS WITH HEART FAILURE AND MILDLY REDUCED LEFT VENTRICULAR EJECTION FRACTION: RESULTS FROM INTERNATIONAL COLLABORATIVE LBBAP STUDY (I-CLAS) GROUP. HEART RHYTHM. 2025; 22:1512¿1522. DOI: 10.1016/J.HRTHM.2024.09.030 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 CONDUCTION SYSTEM PACING COMPARED WITH BIVENTRICULAR PACING FOR CARDIAC RESYNCHRONIZATION THERAPY (CRT). THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN AND DESCRIBED AS ALL-CAUSE MORTALITY. THERE WERE PATIENTS WHO EXPERIENCED HEART FAILURE HOSPITALIZATIONS AND PROCEDURAL COMPLICATIONS SUCH AS PERICARDIAL EFFUSION, PNEUMOTHORAX, INFECTION, PERFORATION, AND HEMATOMA WHICH REQUIRED INTERVENTION. THERE WERE LEADS WHICH EXHIBITED INCREASES IN THRESHOLDS AND DISLODGEMENTS AND REQUIRED LEAD REVISIONS. 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
    554354 MEDTRONIC IPG PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| L| H UNKNOWN COMPETITOR LEAD