BEUDAMED
    FDA Adverse Event Other Summary report: N

    CADENCE PHYSIO QC ADULT RTS

    MDR report key: 2253166 · Received September 1, 2011

    Report

    Report Number
    1219103-2011-00004
    Event Type
    Other
    Date Received
    September 1, 2011
    Date of Event
    April 22, 2011
    Report Date
    August 4, 2011
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. THE DEVICE HISTORY RECORDS FOR THE FINISHED PRODUCT LOTS, AND THOSE COMPONENTS USED IN THE MANUFACTURE OF THE FINISHED GOOD, WERE REVIEWED FOR MACHINE PROBLEMS AND DISPARITIES. ALL IN-PROCESS INSPECTIONS AND SAMPLING PLANS MET THE APPLICABLE ACCEPTANCE CRITERIA. A SAMPLE WAS RECEIVED FROM THE CUSTOMER FOR REVIEW AND RECEIVED IN A CONFIGURATION SUCH THAT THE ELECTRODES WERE ADHERED TO THE INSIDES OF THE FOIL POUCH. AS EXPECTED IN A USED PRODUCT SAMPLE, THE ELECTRODE GEL WAS OBSERVED TO EXHIBIT SIGNS OF "DRY OUT," RESULTING IN LOSS OF ADHESIVE STRENGTH. THIS OCCURS AS THE RESULT OF EXPOSURE OF THE PRODUCT TO AIR AFTER OPENING THE PROTECTIVE FOIL POUCH. THE ELECTRODES WERE VISUALLY INSPECTED FOR KNOWN CAUSES FOR SKIN BURNS RELATED TO THE MANUFACTURING ASSEMBLY OF THE ELECTRODES INCLUDING SILVER INK PATTERN, GEL DELAMINATION, AN ABSENCE OF THE CONDUCTIVE MESH, AND DISTRIBUTION OF THE WIRE FIBERS (COMMONLY REFERRED TO AS THE WIRE FAN). THE EVALUATION OF THE SAMPLES CONFIRMED THAT THE PRODUCT WAS PRODUCED ACCORDING TO APPROVED SPECIFICATIONS. DUE TO THE CONDITION OF THE SAMPLES, ELECTRICAL PERFORMANCE TESTING WAS NOT CONDUCTED. THE MEDI-TRACETM CADENCE DEFIBRILLATION ELECTRODES EMPLOY A UNIQUE SILVER/SILVER CHLORIDE DESIGN RESULTING IN A MORE UNIFORM DISTRIBUTION OF CURRENT DURING DEFIBRILLATION, PACING AND CARDIOVERSION. THIS UNIFORM CURRENT DISTRIBUTION HELPS TO REDUCE THE PROBABILITY AND EXTENT OF SKIN IRRITATION, BUT IT DOES NOT ELIMINATE IT. DEFIBRILLATION IRRITATION IS CAUSED BY THE PROPENSITY OF ELECTRICAL CURRENT TO TRAVEL TO THE EDGES OF AN ELECTRODE BEFORE ENTERING THE SKIN. THIS SO-CALLED "EDGE EFFECT" IS PRESENT TO SOME DEGREE IN ALL DEFIBRILLATION ELECTRODES. TO REDUCE THE LIKELIHOOD AND EXTENT OF SKIN IRRITATION, IT IS IMPORTANT THERE BE GOOD CONTACT SURFACE AREA CONTACT BETWEEN THE ELECTRODE AND THE PATIENT SKIN. AS SUCH, THE IFU RECOMMENDS CLEANING AND LIGHTLY ABRADING THE SKIN PRIOR TO ELECTRODE APPLICATION TO HELP REDUCE THE CONTACT IMPEDANCE. SMOOTHING THE ELECTRODE AS IT IS APPLIED WILL HELP REMOVE ANY TRAPPED AIR. MOVEMENT OF THE PATIENT SHOULD BE MINIMIZED AFTER ELECTRODE PLACEMENT TO PREVENT THE ELECTRODE FROM DISENGAGING FROM THE SKIN. IT IS ALSO IMPORTANT TO NOTE THAT THE HYDROGEL USED IN THIS SET OF ELECTRODES HAS PASSED ALL BIOCOMPATIBILITY REQUIREMENTS AS INDICATED IN (B)(4). THIS INCLUDES PASSING TESTS FOR CYTOTOXICITY, PRIMARY SKIN IRRITATION AND SKIN SENSITIZATION. IT SHOULD BE NOTED THAT THE CLINICIAN INDICATED THAT THE PATIENT HAS ICHTYOSIS, A SKIN DISORDER RESULTING IN DRY, THICKENED, SCALY OR FLAKY SKIN. AS NOTED ABOVE, THE PREPARATION AND CONDITION OF THE SKIN AFFECTS THE ADHESION OF THE ELECTRODE AND THEREFORE CURRENT TRAVEL AND DISTRIBUTION DURING DEFIBRILLATION, PACING AND CARDIOVERSION. AS NO ASSIGNABLE MANUFACTURING CAUSE FOR THE EVENT DESCRIBED CAN BE IDENTIFIED AT THIS TIME, CORRECTIVE ACTIONS ARE NOT DEEMED NECESSARY. WE WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS ISSUE AND TAKE ACTION AS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011, THAT A CUSTOMER HAD AN ISSUE WITH A DEFIBRILLATION ELECTRODE. THE CUSTOMER STATED THAT THE PATIENT SUFFERED A BURN AFTER A CARDIO-VERSION ATTEMPT BUT NO KNOWN MEDICAL INTERVENTION WAS REQUIRED. ON (B)(6) 2011, COVIDIEN RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT'S BURN WAS A 2ND DEGREE BURN AND REQUIRED TREATMENT WITH SILVADENE AND NEURONTIN. THE CUSTOMER STATED THAT THE BURN WAS POSSIBLY RELATED TO THE PATIENT'S SECONDARY SKIN DISORDER, ICHTHYOSIS, A RARE DISORDER THAT LEAVES THE SKIN DRY AND SCALY WHICH INHIBITED THE COMPLETE ADHESION OF THE DEFIBRILLATION ELECTRODE. THE CUSTOMER ADDITIONALLY STATES THAT THE PATIENT'S BURN WAS MOSTLY HEALED 3 DAYS AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADENCE PHYSIO QC ADULT RTS DEFIBRILLATION ELECTRODE MLN COVIDIEN 22550R 109117

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other