BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 1998214 · Received February 22, 2011

    Report

    Report Number
    9612355-2011-00004
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT BIOSENSE WEBSTER PRODUCTS USED DURING THE PROCEDURE: EZ STEER NON - NAVIGATIONAL 8MM (DS) CATHETER; CATALOG NO.: BD7TCDF8L; LOT NO.: 15139940. REDEL NON-NAVIGATIONAL CABLE; CATALOG NO.: C10MRMSTKDTCS. LOT NO.: UNKNOWN. THE PHYSICIAN STATED THAT THE BIOSENSE WEBSTER PRODUCT WAS NOT AT FAULT, AND IT WAS BELIEVED THAT THE PATCH WAS LIFTED OFF THE SKIN AND CAUSED THE BURN. THE IFU RECOMMENDS PLACING THE INDIFFERENT ELECTRODE ON THE BACK AS CLOSE TO THE HEART AS POSSIBLE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS REVIEWED POST DEVICE EVALUATION AND UPON REVIEWING THE INFORMATION PROVIDED BY THE CUSTOMER. IT WAS EVIDENT THAT THE EVENT OCCURRED DUE TO USAGE OF THE PRODUCT HOWEVER, THERE WAS NO SERIOUS INJURY TO THE PATIENT AND THERE WAS NO INTERVENTION NEEDED TO PREVENT ANY PERMANENT DAMAGE AS INDICATED BY THE FACILITY. THE PATIENT WAS DISCHARGED FROM THE FACILITY AT A LATER DATE WITHOUT ANY CONSEQUENCES. ADDITIONAL DETAILS ARE NOT PROVIDED BY THE FACILITY. BWI HAS RE-CLASSIFIED THIS EVENT AS NOT REPORTABLE IN LIGHT OF THIS INFORMATION. IF ANY ADDITIONAL UPDATES OR NEW INFORMATION IS PROVIDED BY THE CUSTOMER, BWI WILL SUBMIT A 3500A SUPPLEMENTAL AS NEEDED. (B)(4). THE VALLEY LAB PATCH WAS REMOVED AND IT WAS NOTED THAT THE PATIENT HAD A FIRST DEGREE BURN UNDERNEATH THE PATCH. IT WAS BELIEVED THAT THE PATCH WAS LIFTED OFF THE SKIN AND CAUSED THE BURN. HOSPITAL PERSONNEL STATED THAT THE GENERATOR WAS NOT AT FAULT AND DID NOT NEED TO BE RETURNED FOR ANALYSIS. IT IS RECOMMENDED THAT THE INDIFFERENT ELECTRODE PATCH BE ATTACHED ON DRY SURFACE OF THE SKIN ON THE BACK OF THE PATIENT NEAR THE HEART. THE IFU PROVIDES PROPER DIRECTIONS ABOUT THE APPLICATION OF THE PATCH AND APPROPRIATE WARNINGS AS INDICATED ON PAGES 22 AND 73 OF THE STOCKERT MANUAL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AVNRT PROCEDURE, THE PATIENT COMPLAINED OF A HEAT SENSATION JUST BELOW THE LEFT FLANK. THE VALLEY LAB PATCH ((B)(4) LOT 173849) WAS REMOVED AND IT WAS NOTED THAT THE PATIENT HAD A FIRST DEGREE BURN UNDERNEATH THE PATCH. A SECOND PATCH WAS PLACED ON THE PATIENT'S RIGHT SHOULDER AND ADDITIONAL LESIONS WERE APPLIED. THERE WAS NO REDDING OF THE SKIN IN THE NEW AREA. THE PHYSICAN STATED THAT THE BWI CATHETER ((B)(4) LOT:15139940) WAS NOT INVOLVED. IT WAS BELIEVED THAT THE PATCH WAS LIFTED OFF THE SKIN AND CAUSED THE BURN. AT THIS TIME, NO TREATMENT WAS GIVEN TO THE PATIENT AND THE PATIENT IS EXPECTED TO BE DISCHARGED ACCORDING TO REGULAR PROTOCOL.

    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