BEUDAMED
    FDA Adverse Event Summary report: N

    CLEARTRACE ADULT ECG ELECTRODE

    MDR report key: 2000539 · Received February 24, 2011

    Report

    Report Number
    1320894-2011-00008
    Date Received
    February 24, 2011
    Date of Event
    October 19, 2010
    Report Date
    February 24, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K946273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS NOT RECEIVED BY LIFEWATCH SERVICES INC. UNTIL A MONTH AND A HALF AFTER THE PATIENT RETURNED HIS KIT. THE ELECTRODES WERE DISCARDED AS PART OF THE RETURN PROCESS. THE LOT NUMBER OF THE ELECTRODES IS UNKNOWN THEREFORE A DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW CANNOT BE ACCOMPLISHED. I AM FILING THIS MEDWATCH REPORT DUE TO A PATIENT REPORTED INJURY WITH THE CAUSE BEING REPORTED AS THE SUSPECT DEVICE. DURING THE CARDIAC MONITORING SERVICE PROVIDED BY LIFEWATCH SERVICES INC., THE PATIENT WENT THROUGH THREE (3) DIFFERENT ECG ELECTRODES. TWO (2) ECG ELECTRODES MADE BY ANOTHER MANUFACTURER AND THE CONMED CLEARTRACE ECG ELECTRODE. IT IS INCONCLUSIVE WITH THE INFORMATION AVAILABLE THAT IF THE ECG ELECTRODE WAS THE CAUSE OF THIS INCIDENT, WHICH MANUFACTURER'S ELECTRODE CAUSED THE SKIN IRRITATION. IN THE PATIENT INTERVIEW CONDUCTED BY LIFEWATCH SERVICES INC., THE PATIENT STATED THAT LAST YEAR (2009) HE HAD A (B)(6) INFECTION ON HIS WRIST FROM A SCRATCH FROM TWO (2) NAILS IN HIS HOUSE THAT IS UNRELATED TO THIS EVENT. THE PATIENT FEELS AS IF THE ELECTRODES CAUSED THE NEW (B)(6) INFECTION. COMMENTS FROM LIFEWATCH SERVICES INC. INCLUDE: "IT IS NOT 100% CLEAR THAT THE (B)(6) INFECTION THE PATIENT RECEIVED (THIS EVENT) WAS CAUSED BY THE ELECTRODES USED DURING HIS MONITORING SERVICE FOR ENROLLMENT PERIOD (B)(6) 2010." THE PATIENT INTERVIEW REVEALED THAT THE "PATIENT PERSPIRED HEAVILY AND HAD TO CHANGE ELECTRODES EVERY 2 TO 3 DAYS". CLEARTRACE ECG ELECTRODES ARE NOT MANUFACTURED FOR USE IN THE DIAPHORETIC PATIENT. THE PATIENT SHOULD HAVE BEEN PRESCREENED BY THE MONITORING SERVICE COMPANY AND AN ALTERNATE ECG ELECTRODE SHOULD HAVE BEEN PROVIDED THAT IS INTENDED TO BE UTILIZED WITH THE DIAPHORETIC PATIENT. THE PATIENT INTERVIEW ALSO REVEALED THE PATIENT PREPARED THE ECG ELECTRODE SITES BY SHAVING HAIR AND CLEANING THE SITE WITH SOAP. THE IFU, INSTRUCTIONS FOR USE, STATE, "SHAVE EXCESSIVE HAIR AT ELECTRODE SITE. FOR OILY SKIN, CLEANSE WITH ALCOHOL PAD AND LET DRY COMPLETELY BEFORE APPLYING ELECTRODE. PREPARE SITE WITH A BRISK, DRY RUB. AVOID DAMAGE OR ABRASION OF SKIN SURFACE." THE PATIENT INTERVIEW ALSO REVEALED THE PATIENT REMOVED THE ECG ELECTRODES WITH A "QUICK PULL/RIP WITHOUT WARM WATER". THE IFU INSTRUCTS, "TO REMOVE ELECTRODE, LIFT TAB OR EDGE OF THE ELECTRODE AND PEEL BACK IN A CONTINUOUS MOTION". THE IFU FURTHER CAUTIONS THAT, "RAPID REMOVAL OF ELECTRODE FROM THE PATIENT MAY CAUSE SKIN DAMAGE. IF THE ELECTRODE IS DIFFICULT TO REMOVE, USE ALCOHOL TO MOISTEN THE ADHESIVE-SKIN INTERFACE". WITH THE INFORMATION AVAILABLE THERE IS NO CONCLUSIVE EVIDENCE THAT THE CONMED CLEARTRACE ECG ELECTRODE CAUSE THE PATIENT REPORTED (B)(6) INFECTION. NO CORRECTIVE ACTIONS ARE PLANNED AT THE PRESENT TIME. CONMED CONSIDERS THIS COMPLAINT CLOSED. DEVICE DISCARDED BY END-USER.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PATIENT COMPLAINT THAT INVOLVED CONMED ELECTRODES IN CONJUNCTION WITH THE ACT SENSOR. ON (B)(6) 2010, LIFEWATCH SERVICES, INC. WAS MADE AWARE BY THE PHYSICIAN'S OFFICE, THAT A PATIENT WHOSE CARDIAC MONITORING ENROLLMENT PERIOD WAS (B)(6) 2010 THROUGH (B)(6) 2010, DEVELOPED A (B)(6) INFECTION WHILE BEING MONITORED. THE PATIENT REPORTED THAT LITTLE ACNE BUMPS AND THAT HE DEVELOPED A (B)(6) INFECTION WHERE HE WORE THE ELECTRODES. SYMPTOMS INCLUDED REDDISH SKIN, BLISTERS AND FLUID DISCHARGE THE ENTIRE SIZE OF THE ELECTRODE. PATIENT HAD TO TERMINATE HIS ENROLLMENT A WEEK EARLY. LIFEWATCH SERVICES INC., (B)(4), CONDUCTED A PATIENT INTERVIEW ON (B)(6) 2010. IN THE INTERVIEW THE SKIN IRRITATION REACTION STARTED BY THE END OF THE SECOND WEEK OF CARDIAC MONITORING (AROUND (B)(6) 2010) UNDER ONE ELECTRODE. THE PATIENT ALSO REPORTED THAT THEY HAD LIGHT SKIN THAT IS SENSITIVE TO ADHESIVES. THE INTERVIEW REVEALED THE SKIN IRRITATION WAS THE SIZE OF THE ELECTRODE, REDDISH RINGS, AND LITTLE ACNE BUMPS APPEARED THAT DEVELOPED INTO A ITCHY-WATERY BLISTER. THE PATIENT STATED THAT HE USED TRIAMCINOLONE ACETONIDE WITHOUT A DOCTOR'S CONSENT WHICH HE HAD LEFT OVER FROM A (B)(6) INFECTION THAT HE HAD THE PREVIOUS YEAR (UNRELATED) IN 2009. HE EVENTUALLY SOUGHT MEDICAL ATTENTION FROM THE SAME GENERAL PRACTITIONER FROM 2009 AND RECEIVED SEVEN (7) DAYS OF ANTIBIOTICS. THE SKIN IRRITATION WAS COMPLETELY HEALED AT THE TIME OF THE INTERVIEW. ECG ELECTRODES WERE DISPOSED OF BY THE END-USER AND LIFEWATCH SERVICES DOES NOT HAVE THE LOT NUMBER. NO PICTURES OF THE REPORTED SKIN IRRITATION WERE MADE AVAILABLE. LIFEWATCH SERVICES INC., REVIEWED THE PATIENT MISCELLANEOUS CALL RECORDS AND ORDER NOTES THAT OCCURRED DURING PATIENT'S CARDIAC MONITORING SERVICE, AND THERE WERE NO INDICATIONS OF THE SEVERITY OF THE INCIDENT ((B)(6) INFECTION) ONLY THAT THE PATIENT REPORTED THAT HE HAD SKIN IRRITATION WHILE WEARING ELECTRODES AND ALTERNATIVE ELECTRODES, CLEARTRACE, WERE ORDERED AND SHIPPED TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention