BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 2200511 · Received August 11, 2011

    Report

    Report Number
    9612355-2011-00026
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 12, 2011
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 3500A SUPPLEMENTAL WILL BE SUBMITTED TO THE FDA AS REQUIRED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE CUSTOMER. (B)(4). AFTER A FOLLOW UP, THE CUSTOMER CONFIRMED THAT THIS WAS NOT A RESULT OF BWI EQUIPMENT ISSUES. IMPEDANCE ISSUE WAS RESOLVED BY REBOOTING THE STOCKERT. NO SERVICE REQUESTED. THE CUSTOMER IS CURRENTLY USING THIS DEVICE WITHOUT ISSUES. THE DEVICE HISTORY RECORD FOR STOCKERT GENERATOR SERIAL NUMBER (B)(4) SHOWS THAT NO MANUFACTURING OR TEST FAILS WERE NOTED DURING THE MANUFACTURING CYCLE RELATED TO FUNCTIONALITY OF THE DEVICE. THE DEVICE MET ALL REQUIREMENTS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT NONE OF THE BWI PRODUCTS CAUSED THIS ISSUE AND NO SERVICE IS REQUESTED AT THIS TIME. THE CATHETERS INVOLVED IN THIS EVENT WERE DISCARDED AND WILL NOT BE RETURNED TO BWI FOR ANALYSIS. ACCORDING TO THE CUSTOMER, THE PATIENT DID NOT SUFFER ANY INJURIES FROM THIS PROCEDURE. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, CATALOG # FG540000, SERIAL # (B)(4), COOLFLOW IRRIGATION PUMP, CATALOG # CFP002, SERIAL # (B)(4). NAVISTAR THERMOCOOL ELECTROPHYSIOLOGY CATHETER, CATALOG # UNKNOWN, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN AFIB ABLATION PROCEDURE, A STEAM POP OCCURRED. THERE WAS A HARDWARE ERROR NOTED DUE TO AN IMPEDANCE SPIKE. THE PATIENT WAS MONITORED WITH ICE CATHETER AND NO ADDITIONAL TREATMENT WAS REQUIRED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other