BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOBLATE

    MDR report key: 19688249 · Received July 8, 2024

    Report

    Report Number
    2184009-2024-00395
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    April 10, 2024
    Report Date
    July 8, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    OCL
    PMA / PMN Number
    K223508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION AUTHORS: GRETA RADAUSKAITE, GEDIMINAS RACKAUSKAS, SVETLANA DANILENKO, VILIUS JANUSAUSKAS AND AUDRIUS AIDIETIS JOURNAL NAME: JOURNAL OF CLINICAL MEDICINE YEAR: 2024 ISSUE NUMBER:13, 2195 TITLE OF ARTICLE: LONG-TERM RESULTS OF THE MINI MAZE STANDALONE BI-ATRIAL SURGICAL ABLATION: A 10-YEAR FOLLOW-UP LITERATURE REFERENCE: DOI.ORG/10.3390/JCM13082195 B3 (EVENT DATE): THE PUBLISHED DATE HAS BEEN USED AS THE EVENT DATE. 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 THE LONG-TERM RESULTS OF A MINI MAZE STANDALONE BI-ATRIAL STUDY. CARDIOBLATE GEMINI DEVICES WERE USED TO TREAT THE PATIENTS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: TRANSIENT ISCHEMIC ATTACK, POST-OPERATIVE BLEEDING REQUIRING A THORACOTOMY, AND POST-OPERATIVE RESPIRATORY TRACT INFECTIONS, TREATED WITH ANTIBIOTICS. BASED ON THE AVAILABLE INFORMATION, THE TRANSIENT ISCHEMIC ATTACK AND POST-OPERATIVE BLEEDING MAY HAVE BEEN ATTRIBUTED TO THE MEDTRONIC PRODUCT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO THE MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170479 CARDIOBLATE SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING OCL PERFUSION SYSTEMS 49260

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention