BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDTEMP¿

    MDR report key: 23285397 · Received October 15, 2025

    Report

    Report Number
    9612164-2025-05059
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    February 1, 2025
    Report Date
    October 13, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    OAE
    PMA / PMN Number
    P200028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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. THE AUTHORS DESCRIBED THERE WERE PATIENTS WHO EXPERIENCED VT RECURRENCE (5), DYSURIA (1), STROKE (1), INCESSANT VT / ELECTRICAL STORM (3), INDUCTION OF VTS OF VARIOUS MORPHOLOGIES DURING ABLATION PROCEDURE AND FEMORAL BLEEDING FROM VASCULAR ACCESS (1). NO INTERVENTION WAS REPORTED. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/68 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: SAFETY AND EFFICACY OF A TEMPERATURE-CONTROLLED ABLATION SYSTEM FOR VENTRICULAR TACHYCARDIA: RESULTS FROM THE TRAC-VT STUDY CIRCULATION: JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2025; HTTPS://DOI.ORG/10.1007/S10840-025-01995 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 CATHETER ABLATION USING RADIOFREQUENCY (RF) ENERGY FOR TREATMENT FOR VENTRICULAR TACHYCARDIA (VT). DURING THE PROCEDURES, FOUR STEAM POPS OCCURRED NONE OF THE STEAM POPS RESULTED IN AN ADVERSE EVENT NOR CONTINUING PATIENT SEQUELA. IN ONE PROCEDURE CHAR/COAGULUM WAS OBSERVED AND THERE WAS NO ADVERSE EVENT. THE AUTHORS DESCRIBED THERE WERE PATIENTS WHO EXPERIENCED VT RECURRENCE (5), DYSURIA (1), STROKE (1), INCESSANT VT / ELECTRICAL STORM (3), INDUCTION OF VTS OF VARIOUS MORPHOLOGIES DURING ABLATION PROCEDURE AND FEMORAL BLEEDING FROM VASCULAR ACCESS (1). NO INTERVENTION WAS REPORTED. THE STATUS OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482804 DIAMONDTEMP¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC IRELAND CEDTB400L UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Life Threatening CEDTB400L CATHETER.