BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASMABLADE 3.0 WIDE SPATULA

    MDR report key: 3975716 · Received August 4, 2014

    Report

    Report Number
    1226420-2014-00056
    Event Type
    Injury
    Date Received
    August 4, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K093695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT# (B)(4). EVALUATION (METHOD), (RESULT): DEVICE NOT RETURNED; THEREFORE, ANALYSIS UNABLE TO BE PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A PACEMAKER GENERATOR EXCHANGE WITH A PACEMAKER DEPENDENT PATIENT, THE PLASMABLADE WAS ACTIVATED AND THE PACING OUTPUT OF THE PACEMAKER AND THE PATIENT'S HEART RATE DROPPED TO 30 BPM. WHEN PLASMABLADE WAS DEACTIVATED, THE PACEMAKER OUTPUT AND THE PATIENT'S HEART RATE REMAINED LOW FOR 10-14 MORE SECONDS BEFORE INCREASING BACK TO A NORMAL RATE. A TEMPORARY PACEMAKER WAS HOOKED UP THE CASE CONTINUED WITHOUT FURTHER INCIDENT. PACEMAKER BEING REPLACED WAS AT THE ERI (ELECTIVE REPLACEMENT INTERVAL = NEAR END OF BATTERY LIFE) REFERENCE LINK BELOW TO LETTER ISSUED BY ST. JUDE INDICATING THAT THE USE OF ELECTROSURGERY IN CONJUNCTION WITH CERTAIN PACEMAKER MODELS CAN RESULT IN AN FUNCTIONAL IMPACT TO THE PACEMAKER (REDUCED OUTPUT OR LACK OF OUTPUT). HTTP://PROFESSIONAL.SJM.COM/PROFESSIONAL/RESOURCES/PRODUCT-P ERFORMANCE/PACEMAKER-012914-COMMUNICATION/PHYSICIAN-COMMUNICATION 7/24/2014 (BOISVK1): VIA RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH PACEMAKER INTERFERENCE, THIS PE WAS DETERMINED TO BE REPORTABLE. DATE OF RETROSPECTIVE REVIEW (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454021 PLASMABLADE 3.0 WIDE SPATULA ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC PS210-030S FL50793051

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR