BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARTRACE ADULT ECG ELECTRODE

    MDR report key: 4077178 · Received September 10, 2014

    Report

    Report Number
    1320894-2014-00087
    Event Type
    Injury
    Date Received
    September 10, 2014
    Report Date
    August 14, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K091856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE CLEARTRACE ECG ELECTRODES WERE DISCARDED BY THE END-USER. IN ADDITION, NO VISUAL EVIDENCE (PHOTOGRAPHS) OF THE DEVICES OR ALLERGIC REACTION WERE PROVIDED BY THE END-USER. WITHOUT THE INVOLVED DEVICES, AN EVALUATION COULD NOT BE PERFORMED. HOWEVER, BASED ON AVAILABLE INFORMATION, WHICH INDICATED THAT THIS REPORTED INCIDENT WAS RELATED TO THE PATIENT'S ALLERGIC REACTION TO THE NICKEL COATING MATERIAL ON THE SNAPS USED WITH THE CLEARTRACE ECG ELECTRODES. A REVIEW OF THE DEVICE LOT HISTORY RECORD COULD NOT BE PERFORMED, AS THE LOT NUMBER WAS NOT PROVIDED BY THE END USER. A TWO (2) YEAR REVIEW OF THE COMPLAINT HISTORY FOR THIS DEVICE REVEALS TWENTY-SIX (26) REPORTS OF ALLERGIC REACTIONS RECEIVED. HOWEVER, THESE TWENTY-SIX (26) ALLERGIC REACTIONS WERE ALL RELATED TO THE DELAYED REACTION ALLERGIES, OR CELL-MEDIATED HYPERSENSITIVITIES SYMPTOMATICALLY EXHIBITED AS CONTACT DERMATITIS OR SKIN ERUPTIONS. IN THIS INSTANCE, THIS PARTICULAR PATIENT EXHIBITED AN ATOPIC ALLERGIC REACTION WHERE THE ALLERGY TRIGGERS A LOCAL INFLAMMATORY REACTION WITH ACCOMPANYING TISSUE DAMAGE, AND, SYMPTOMATICALLY DISPLAYED AS AN ANAPHYLACTIC REACTION OCCURRING THROUGHOUT THE PATIENT'S SYSTEM. THIS REPORTED OF AN ATOPIC ALLERGIC REACTION TO THE NICKEL COATING MATERIAL IS AN ISOLATED INCIDENT IN THE TWO (2) YEAR COMPLAINT HISTORY REVIEW. DURING THIS SAME TWO YEAR PERIOD THERE WERE OVER (B)(4) DEVICES SOLD WORLDWIDE MAKING THE OCCURRENCE RATE FOR THIS TYPE OF ALLERGIC REACTION (B)(4) PERCENT. AS PREVIOUSLY REPORTED, NEITHER THE PATIENT NOR HER MEDICAL PROVIDER NOTIFIED LIFEWATCH SERVICES, THE PROVIDER OF THE CLEARTRACE ECG ELECTRODES, THAT SHE HAD A SEVERE ALLERGY TO NICKEL. PER THE TECHNICAL DATA SHEET FOR THE CLEARTRACE ECG ELECTRODES, THE SNAP OF THE DEVICE IS CONSTRUCTED OF NICKEL PLATED BRASS. IN THIS INSTANCE, IT IS BELIEVED THAT THE REPORTED INCIDENT COULD HAVE BEEN AVOIDED IF THE PATIENT'S ALLERGIC REACTION TO NICKEL CONDITION WAS MADE AWARE TO LIFEWATCH SERVICES, SO THAT ALTERNATE CARBON SNAP COULD BE USED WITH THE CLEARTRACE ECG ELECTRODES. THE CLEARTRACE ECG ELECTRODE IS AN ELECTROCARDIOGRAPH ELECTRODE, AN ELECTRICAL CONDUCTOR WHICH IS APPLIED TO THE SURFACE OF THE BODY INTENDED TO TRANSMIT THE ELECTRICAL SIGNAL AT THE BODY SURFACE TO A PROCESSOR VIA LEAD WIRES AND CABLES THAT PRODUCE AN ELECTROCARDIOGRAM TO BE USED BY THE CLINICIAN IN DIAGNOSING OR MONITORING A PATIENT'S CONDITION. THIS PRODUCT IS A SINGLE USE, DISPOSABLE DEVICE. OTHER THAN THIS REPORTED INCIDENT, TO DATE THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS OF "NICKEL ALLERGIC REACTION" RECEIVED FOR THIS DEVICE. DEVICE NOT RETURNED TO CONMED CORP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, LIFEWATCH SERVICES, INC. REPORTED TO CONMED CORPORATION THAT THE (B)(6) YEAR OLD, FEMALE PATIENT WAS ENROLLED FOR HOME CARDIAC MONITORING FOR A PERIOD FROM (B)(6) 2014. REPORTEDLY, CONMED CLEARTRACE ECG ELECTRODES WERE USED IN CONJUNCTION WITH THE ACT III SENSOR MONITOR. ALLEGEDLY, THE PATIENT REPORTED THAT SHE HAS A TERRIBLE ALLERGY TO NICKEL AND EXPERIENCED AN ALLERGIC REACTION INCLUDING: SKIN BLISTERING, SWOLLEN THROAT, AND THAT SHE PASSED OUT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND INFORMED LIFEWATCH SERVICES OF HER REACTION AFTER HER HOSPITAL DISCHARGE. SPECIFIC PATIENT TREATMENT DURING THE HOSPITALIZATION IS UNKNOWN. LIFEWATCH SERVICES, INC. WAS INFORMED OF THE INCIDENT ON (B)(6) 2014. HOWEVER, LIFEWATCH SERVICES DID NOT REPORT THE INCIDENT TO CONMED UNTIL (B)(6) 2014. AN INVESTIGATION BY LIFEWATCH SERVICES, INC. REVEALED THAT NEITHER THE PATIENT NOR HER PHYSICIAN HAD INFORMED LIFEWATCH OF THE PATIENT'S ALLERGY TO NICKEL PRIOR TO THE DELIVERY OF THE HOME CARDIAC MONITORING DEVICES. THE ELECTRODES WERE NOT RETURNED TO LIFEWATCH SERVICES; THEREFORE, THE ELECTRODES ARE NOT AVAILABLE FOR EVALUATION BY CONMED CORPORATION. FOLLOW-UP WITH THE PATIENT AND HER NURSE PRACTITIONER BY LIFEWATCH SERVICES PERSONNEL HAS LEARNED THAT SHE IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557577 CLEARTRACE ADULT ECG ELECTRODE CLEARTRACE ECG ELECTRODE DRX CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O ACT III SENSOR CARDIAC MONITOR-NOT A CONMED DEVICE