BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EMPRINT GENERATOR

    MDR report key: 23827342 · Received December 17, 2025

    Report

    Report Number
    3004962788-2025-00133
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    September 18, 2025
    Report Date
    December 17, 2025
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNK EMPRINT ANT, UNKNOWN EMPRINT ANTENNA (LOT#UNKNOWN). PREDICTING TUMOR RECURRENCE WITH EARLY 18F-FDG PET-CT AFTER THERMAL AND NON-THERMAL ABLATION / GOVINDARAJAN NARAYANAN, NICOLE T. GENTILE, BRIAN J. SCHIRO, RIPAL T. GANDHI, CONSTANTINO S. PEÑA, SUSAN VAN DER LEI, AND MADELON DIJKSTRA. / CURR. ONCOL. 2025, 32, 521 / PUBLISHED: 18 SEPTEMBER 2025 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

    ACCORDING TO THE LITERATURE, POST-OPERATIVELY, A RETROSPECTIVE ANALYSIS OF PATIENTS WITH (POSITRON EMISSION TOMOGRAPHY¿COMPUTED TOMOGRAPHY) PET-CT SCANS WITHIN 24 HOURS AFTER IMAGE-GUIDED TUMOR ABLATION WAS USED TO SEE IF TREATMENT SUCCESS COULD BE PREDICTED BY THE POSTOP IMAGING. 153 PATIENTS BETWEEN AUGUST 2018 AND FEBRUARY 2024 WERE IDENTIFIED FROM THE ELECTRONIC MEDICAL RECORDS, AND 24 PATIENTS WERE EXCLUDED. OF THE EXCLUDED PATIENTS, 3 WERE EXCLUDED AS THEY REQUIRED IMMEDIATE RE-TREATMENT. NO FURTHER SPECIFICATION/INFORMATION WAS AVAILABLE FOR THE RE-TREATMENT GROUP AND NO OTHER PATIENT COMPLICATIONS WERE DOCUMENTED IN THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040900 UNKNOWN EMPRINT GENERATOR SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN LP - SUPERDIMENSION INC UNKNOWN EMPRINT GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention PLEASE SEE NOTE ON H11