BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAE UNKNOWN PLASMABLADE DEVICE

    MDR report key: 6214505 · Received December 29, 2016

    Report

    Report Number
    1226420-2016-00205
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    November 30, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 WHEN ACTIVATED ON CUT 5 WAS CAUSING INTERFERENCE AND INHIBITING PACING WITH A ST JUDE ICD, V PACED PATIENT. NO FURTHER CASE DETAILS AVAILABLE. THERE WAS NO IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862808 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