BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 3071852 · Received April 22, 2013

    Report

    Report Number
    9612355-2013-00018
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL #:M-4800-01, SERIAL #: (B)(4). COOLFLOW PUMP, MODEL #: M-5491-02, SERIAL #: (B)(4). NAVISTAR, MODEL #: NAVISTAR TC, LOT #: UNKNOWN. PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. REGARDING THE BIOSENSE WEBSTER SYSTEMS, THE CUSTOMER WAS CONTACTED BY A BWI FIELD REPRESENTATIVE. THE HOSPITAL EP LAB STAFF ADVISED THAT THIS ISSUE WAS NOT RELATED TO BWI SYSTEMS. THE CUSTOMER DECLINED SYSTEM SERVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED TO THE BWI FIELD REPRESENTATIVE ON JUNE 7, 2013. THE PROCEDURE WAS A COMPREHENSIVE (B)(4) STUDY WITH MAPPING AND ABLATION FOR ATRIAL FLUTTER AND COMPLEX ATRIAL FIBRILLATION ABLATION. THE GROUNDING PAD (PRE) WAS PLACED ON THE PATIENTS LEFT LOWER BACK PRIOR TO THE PROCEDURE. AFTER THE PROCEDURE, THE PRE WAS REMOVED IN THE CATH LAB. IN THE POS-OP/RECOVERY AREA, THE PATIENTS PAIN AND DISCOMFORT TO THE LEFT LOWER BACK AND A SKIN TEAR WITH REDNESS WAS NOTED. THE PATIENT WAS DIAPHORETIC PRE AND POST POSTURE. THIS EVENT REQUIRED EXTENDED HOSPITAL STAY. THE OUTCOME OF THIS ADVERSE EVENT WAS UNKNOWN. THE PROGNOSIS FOR THE PATIENT WAS SATISFACTORY. THE CAUSALITY OF THE ADVERSE EVENT WAS THE (B)(4) NON-REM POLYHESIVE PATIENT RETURN ELECTRODE ((B)(4), LOT # UNKNOWN ¿ THE PACKAGE WRAPPER WAS DISCARDED). THE PHYSICIAN CONSIDERS THE EVENTS CAUSALITY WAS DUE TO A BWI PRODUCT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND FOLLOWED UP WITH HIS PRIMARY PHYSICIAN. THE ISSUE WAS NOT SPECIFICALLY CLASSIFIED. THE PHYSICIAN¿S IMPRESSION WAS THAT THE OVERALL APPEARANCE OF THE WOUND SUGGESTS THAT THIS MAY BE A BURN WOUND AND BELIEVED TO BE A DEEP PARTIAL THICKNESS WOUND WITH SUGGESTION OF SOME AREAS OF FULL-THICKNESS WOUNDING. THE BURN WAS NOT MEDICALLY TREATED DIFFERENTLY THAN ROUTINE CLINICAL PRACTICE. THE PATIENT WAS GOING TO REQUIRE FURTHER TREATMENT 7-10 DAYS FOLLOWING THE DISCHARGE. THE EVENT WAS NOT LIFE THREATENING. THE EVENT DID NOT RESULT IN PERMANENT NON TRIVIAL IMPAIRMENT. THIS INCIDENT DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE. SETTING ON THE RF GENERATOR WAS VARIABLE. TOTAL ABLATION PROCEDURE WAS 1 HOUR 21 MINUTES AND 53 SECONDS. (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF # (B)(4). IT WAS REPORTED THAT WHILE REMOVING THE PATCH FROM THE PATIENTS FLANK DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATCH HAD SKIN ADHERED TO IT. IT WAS UNKNOWN IF THIS WAS FROM A SKIN BURN OR THE ADHESIVE FROM THE PATCH. THE STOCKERT WAS SENT IN FOR EVALUATION IN ORDER TO RECREATE THE REPORTED CONDITION HOWEVER, THE UNIT WAS FOUND FUNCTIONAL AND READY FOR USE DURING THE SERVICE. FUNCTION TEST AND PREVENTIVE MAINTENANCE WERE PERFORMED TO THE UNIT. NIS BOARD UPGRADE WAS PERFORMED TO THE STOCKERT. ALL UNITS THAT COME FOR SERVICE AND REQUIRE THE UPGRADE TO THE BOARD, IT IS PERFORMED. THE UPGRADE IS TO ENHANCE THE FUNCTIONALITY OF THE BOARD AND IT IS BEING PERFORMED EVEN IF THE UNIT DOES NOT PRESENT ANY MALFUNCTION AS SEEN ON THIS PARTICULAR EVENT. 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 WHILE REMOVING THE PATCH FROM THE PATIENTS FLANK DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATCH HAD SKIN ADHERED TO IT. IT WAS UNKNOWN IF THIS WAS FROM A SKIN BURN OR THE ADHESIVE FROM THE PATCH. IT WAS NOTED THAT THE PATIENT WAS SWEATING. A DERMATOLOGY CONSULT WAS REQUESTED. THE STATUS OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION ON THE EVENT WAS REQUESTED, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172742 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O