BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLASMABLADE DEVICE

    MDR report key: 6954782 · Received October 17, 2017

    Report

    Report Number
    1226420-2017-00256
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    June 10, 2016
    Report Date
    October 17, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). THERE WAS NO CONTACT INFORMATION PROVIDED WITHIN THE JOURNAL, THEREFORE FOLLOW-UP FOR PATIENT INFORMATION WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    ARTICLE: ELECTROCAUTERY COMPARED TO ELECTRICAL PLASMA SURGERY IN PATIENTS UNDERGOING DEVICE GENERATOR REPLACEMENT - A PROSPECTIVE RANDOMIZED STUDY BACKGROUND: AS THE NUMBER OF CARDIAC IMPLANTABLE ELECTRONIC DEVICES IS CONSTANTLY GROWING, THE NEED FOR GENERATOR REPLACEMENT SURGERIES INCREASES. GENERATOR REPLACEMENT IS ASSOCIATED WITH SURGICAL COMPLICATIONS SUCH AS POCKET HEMATOMA, INFECTIONS AND LEAD DAMAGES. CONVENTIONAL ELECTROCAUTERY HAS BEEN SHOWN TO BEAR THE POTENTIAL OF LEAD INSULATION DAMAGE BY FOCAL HEATING. RECENTLY A NOVEL ELECTRICAL PLASMA SURGERY TOOL (PEAK PLASMABLADETM, MEDTRONIC INC., MINNEAPOLIS, MN, USA) HAS BEEN INTRODUCED. THIS TOOL WORKS AT LOWER PEAK TEMPERATURE LEVELS AND IS ABLE TO CUT WET TISSUE AS WELL. THE AIM OF THIS PROSPECTIVE RANDOMIZED SINGLE CENTER STUDY WAS TO COMPARE EFFECTIVENESS AND SAFETY OF THE ELECTRICAL PLASMA SURGERY TOOL WITH A CONVENTIONAL ELECTROCAUTERY TOOL IN DEVICE GENERATOR REPLACEMENT SURGERIES. METHODS: AFTER RANDOMIZATION, 78 PATIENTS UNDERGOING DEVICE GENERATOR REPLACEMENT WERE TREATED EITHER WITH A CONVENTIONAL RADIOFREQUENCY ELECTROCAUTERY TOOL (VIO 100C, ERBE ELEKTROMEDIZIN GMBH, TUBINGEN, GERMANY; N ¼ 38) OR THE ELECTRICAL PLASMA SURGERY TOOL (N ¼ 40). THE PRIMARY ENDPOINT WAS THE DURATION FROM SKIN INCISION TO GENERATOR ENUCLEATION. SECONDARY ENDPOINTS WERE PROCEDURAL DURATIONS, INCIDENCE OF POCKET HEMATOMA, DEVICE INFECTIONS AND LEAD DAMAGES. RESULTS: THE DURATION TO GENERATOR ENUCLEATION WAS SIGNIFICANTLY SHORTER IN THE PLASMA SURGERY GROUP [8 + 5 MIN. VS 13 + 10 MIN.; P ¼ 0.002]. SECONDARY ENDPOINTS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE TWO GROUPS. IN TWO PATIENTS A CROSS OVER FROM THE CONVENTIONAL TREATMENT GROUP TO THE PLASMA SURGERY GROUP WAS NECESSARY DUE TO SEVERE FIBROTIC ADHESIONS. ADVERSE EVENTS: PROLONGED HOSPITALIZATION DUE TO SURGICAL COMPLICATIONS: 2 PATIENTS POCKET HEMATOMA: 15 PATIENTS RE-OPERATION: 2 PATIENTS ALL PATIENT'S ARE GROUPED INTO ONE EVENT DUE TO THE LACK OF UNIQUE PATIENT IDENTIFYING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736231 UNKNOWN PLASMABLADE DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK PEAK DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization