BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR AQM 115V

    MDR report key: 3251743 · Received July 29, 2013

    Report

    Report Number
    1226420-2013-00140
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    May 24, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K052859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, METHOD, RESULTS: GENERATOR IS NOT AVAILABLE FOR RETURN AND INSPECTION; FACILITY CONTINUING TO USE WITH NO FURTHER ISSUES. PRODUCT EVENT: (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

    SURGEON REPORTED POST-OPERATIVE PATIENT INFECTION THAT WAS FIRST TREATED WITH ANTIBIOTICS, THEN DEBRIDEMENT, AND FINALLY SURGICAL INTERVENTION VIA REMOVAL AND CLEANING OF IMPLANT TO TREAT THE INFECTION. POTENTIAL OVERTREATMENT OF SUBCUTANEOUS TISSUE DETERMINED TO BE MOST LIKELY CAUSE BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353556 GENERATOR AQM 115V GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC 40-402-1

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention