BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 2065072 · Received April 20, 2011

    Report

    Report Number
    9612355-2011-00007
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE GENERATOR WAS RETURNED TO THE VENDOR (STOCKERT) FOR ANALYSIS. THE GENERATOR WAS FOUND TO BE FUNCTIONAL DURING INVESTIGATION AND PASSED ALL PERFORMANCE, FUNCTIONAL, AND SAFETY TESTS. THE DEVICE HISTORY RECORD FOR STOCKERT GENERATOR ST-1774 SHOWS THAT NO MANUFACTURING OR TEST FAILS WERE NOTED DURING THE MANUFACTURING OR SERVICE THAT RELATED TO THIS EVENT. THE DEVICE MET ALL REQUIREMENTS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    A 3500A SUPPLEMENTAL WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. BWI CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: US CAT NUM: M480001, (B)(4). COOLFLOW IRRIGATION PUMP: US CAT NUM: CFP002, (B)(4). EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER: US CAT NUM: BNI75TCDFH, (B)(4). LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER: US CAT NUM: D7L202515RT, LOT NUMBER: 15289133L. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING ABLATION ON RIGHT ATRIAL FLUTTER LINE DURING A-FIB PROCEDURE, A STEAM POP OCCURRED. NO TEMPERATURE OR IMPEDANCE SPIKES WERE NOTED. FLUOROSCOPY CONFIRMED PERICARDIAL EFFUSION. THERE WAS NO DROP IN BLOOD PRESSURE SEEN. PERICARDIOCENTESIS WAS PERFORMED RESULTING IN APPROXIMATELY 600CC OF FLUID BEING REMOVED FROM THE PERICARDIAL SPACE. PATIENT WAS MOVED TO ICU FOR ONE DAY. PATIENT PROGNOSIS IS SATISFACTORY AND HAS FULLY RECOVERED. CAUSALITY OF ADVERSE EVENT IS PROCEDURE RELATED.

    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 64 YR Hospitalization| L| R