BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS GENERATOR

    MDR report key: 3994159 · Received August 8, 2014

    Report

    Report Number
    1226420-2014-00063
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K052859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT # (B)(4) EVALUATION METHOD/RESULT/CONCLUSION: GENERATOR STILL IN USE; THEREFORE, ANALYSIS UNABLE TO BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    AFTER A MICRO DISCECTOMY SPINE CASE, WHERE THE AQUAMANTYS SYSTEM WAS UTILIZED, IT WAS REPORTED THAT A PATIENT HAD A LOSS OF FEELING IN HIS ONE LEG BELOW THE KNEE. PATIENT WAS TAKEN BACK INTO SURGERY TWO DAYS LATER FOR A DECOMPRESSION PROCEDURE. AT THE TIME OF THE REPORTED INCIDENT THE PATIENT DID NOT HAVE FEELING IN HIS LEG BACK YET, BUT THE SURGEON STATED THAT HE ANTICIPATES THE SENSORY AND MOTOR FUNCTION TO RETURN TO NORMAL OVER 1 TO 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472489 AQUAMANTYS GENERATOR GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC 40-402-1

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR