BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLASMABLADE DEVICE

    MDR report key: 23016016 · Received September 10, 2025

    Report

    Report Number
    1226420-2025-00040
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    July 1, 2022
    Report Date
    September 10, 2025
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENTS IN THE STUDY. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND IS THEREFORE, UNAVAILABLE. H3: NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DIGITAL SHARING OF THE ARTICLE WOULD BE IN VIOLATION OF COPYRIGHT PERMISSION. 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

    HONG, S. W., PARK, S. H., PHUONG, D. D., CHANG, K. W., JUNG, H. H., & CHANG, J. W. (2025). DEEP BRAIN STIMULATION GENERATOR RE PLACEMENT SURGERIES: SAFETY AND EFFICACY OF PEAK PLASMABLADE TMX AND ANALYSIS OF WOUND HEALING COMPLICATIONS. JOURNAL OF KOREAN NEUROSURGICAL SOCIETY, 68(4), 473¿479. HTTPS://DOI.ORG/10.3340/JKNS.2024.0133 OBJECTIVE: THIS STUDY AIMED TO ASSESS THE SAFETY AND EFFICACY OF USING THE PEAK PLASMABLADE TMX (PBX) IN DEEP BRAIN STIMULATION (DBS) OF IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT SURGERIES, ALONGSIDE IDENTIFYING POTENTIAL RISK FACTORS FOR POSTOPERATIVE COMPLICATIONS. METHODS: A PROSPECTIVE STUDY WAS CONDUCTED ON 50 PATIENTS UNDERGOING IPG REPLACEMENT WITH PBX, COMPARED TO 150 HISTORICAL CONTROLS, DEMOGRAPHIC DATA, SURGICAL CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. LOGISTIC REGRESSION WAS USED TO IDENTIFY PREDICTORS OF SURGICAL COMPLICATIONS. RESULTS: THE DEMOGRAPHIC AND CLINICAL PROFILES OF PATIENTS IN THE PBX GROUP WERE COMPARABLE TO THOSE IN THE CONTROL GROUP, PBX SIGNIFICANTLY REDUCED SURGICAL DURATION (P=0,005) AND DID NOT RESULT IN IMPEDANCE ABNORMALITIES, WHILE WOUND COMPLICATIONS DID NOT SIGNIFICANTLY DIFFER BETWEEN GROUPS, LOGISTIC REGRESSION IDENTIFIED DIABETES AS A SIGNIFICANT PREDICTOR OF WOUND DEHISCENCE OR DELAYED HEALING (P=0,012). CONCLUSION: THE FINDINGS SUPPORT THE SAFETY AND EFFICACY OF PBX IN DBS IPG REPLACEMENT SURGERIES, OFFERING ADVANTAGES SUCH AS REDUCED SURGICAL DURATION AND MINIMIZED RISK OF IMPEDANCE ABNORMALITIES. HOWEVER, DIABETES EMERGED AS A SIGNIFICANT PREDICTOR OF ADVERSE WOUND OUTCOMES, HIGHLIGHTING THE NEED FOR TAILORED PREOPERATIVE ASSESSMENT AND MANAGEMENT STRATEGIES. 1. 2 PATIENTS HAD HEMATOMA AS WOUND RELATED COMPLICATIONS 2. 3 PATIENTS HAD DEHISCENCE/DELAYED HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519647 UNKNOWN PLASMABLADE DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) MAE UNK PEAK DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other