BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF 3000 RADIOFREQUENCY GENERATOR

    MDR report key: 1133208 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03607
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION CANNOT BE PERFORMED. THE CAUSE FOR THE REPORTED EVENT IS UNDETERMINED. THE DEVICE HISTORY RECORDED (DHR) OF THE REPORTED SERIAL NUMBER WAS REVIEWED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    NOTE:THIS MFR REPORT PERTAINS TO ONE OF FIVE DEVICES USED DURING THE SAME PROCEDURE. MFR REPORTS 3005099803-2008-03611,3005099803-2008-03610, 3005099803-2008-03609 AND 3005099803-2008-03608 DESCRIBE THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT AN RF 3000 RADIOFREQUENCY GENERATOR WAS USED FOR A RADIO FREQUENCY ABLATION PROCEDURE (PATIENT AGE, GENDER AND WEIGHT UNKNOWN) ON THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, THE PATIENT RECEIVED A PAD BURN DURING THE PROCEDURE. THE BURN WAS APPROXIMATELY THREE INCHES (DIAMETER), HOWEVER, THE DEGREE OF THE BURN IS UNKNOWN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO ASCERTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF 3000 RADIOFREQUENCY GENERATOR GEI BOSTON SCIENTIFIC CORPORATION M00126220R0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other