BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAE UNKNOWN PLASMABLADE DEVICE

    MDR report key: 6216288 · Received December 30, 2016

    Report

    Report Number
    1226420-2016-00210
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    November 29, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4) PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TWITTER FEED REPORTS; THE PLASMABLADE DEVICE WHEN ACTIVATED ON CUT 5 CAUSED OVER SENSING ON ST JUDE ICD¿S AND INHIBITED PACING EVEN IN VOO (VENTRICULAR ASYNCHRONOUS PACING). THE SURGEON REPORTS THIS HAS HAPPENED IN A TOTAL OF THREE CASES, HOWEVER CASE DETAILS ARE UNKNOWN. THERE WAS NO PATIENT IMPACT REPORTED. THIS RECORD REPRESENTS THE 3RD OF 3 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865887 MAE UNKNOWN PLASMABLADE DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK PEAK DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1