BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 1961810 · Received January 14, 2011

    Report

    Report Number
    3005099803-2011-00112
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K982556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE/DATE OF BIRTH, GENDER, AND WEIGHT ARE UNKNOWN. HOWEVER, PATIENT OVER 18 YEARS OLD. THE REPORTED LOT NUMBER COULD NOT BE MATCHED TO THE REPORTED DEVICE. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN AT THIS TIME. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00089, 3005099803-2011-00110, AND 3005099803-2011-00111 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND THREE LEVEEN NEEDLES ELECTRODES WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE THREE ELECTRODES WERE USED TO PERFORM THE ABLATION FOLLOWING THE STANDARD ALGORITHM. HOWEVER, AFTER APPROXIMATELY 1 MINUTE, THE POWER COULD NOT BE INCREASED AS EXPECTED. THE GENERATOR WAS SWITCHED OFF, THEN ON AND THE PROCEDURE WAS CONTINUED AT THE PREVIOUS POWER OUTPUT. THE CUSTOMER INDICATED THAT THIS ISSUE CAUSED AN INCREASE IN THE PROCEDURE LENGTH. ADDITIONALLY, THE ACCOUNT CONFIRMED THAT ROLL-OFF WAS ABLE TO BE ACHIEVED AND THE PROCEDURE RESULTS WERE PERFECT. HOWEVER, NO INFORMATION WAS ABLE TO BE OBTAINED RELATED TO THE USE OF EACH ELECTRODE FOR THE ABLATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00089, 3005099803-2011-00110, AND 3005099803-2011-00111 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND THREE LEVEEN NEEDLES ELECTRODES WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE THREE ELECTRODES WERE USED TO PERFORM THE ABLATION FOLLOWING THE STANDARD ALGORITHM. HOWEVER, AFTER APPROXIMATELY 1 MINUTE, THE POWER COULD NOT BE INCREASED AS EXPECTED. THE GENERATOR WAS SWITCHED OFF, THEN ON AND THE PROCEDURE WAS CONTINUED AT THE PREVIOUS POWER OUTPUT. THE CUSTOMER INDICATED THAT THIS ISSUE CAUSED AN INCREASE IN THE PROCEDURE LENGTH. ADDITIONALLY, THE ACCOUNT CONFIRMED THAT ROLL-OFF WAS ABLE TO BE ACHIEVED AND THE PROCEDURE RESULTS WERE PERFECT. HOWEVER, NO INFORMATION WAS ABLE TO BE OBTAINED RELATED TO THE USE OF EACH ELECTRODE FOR THE ABLATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262070 13125555

    Patients

    Seq Age Sex Outcome Treatment
    1