BEUDAMED
    FDA Adverse Event Summary report: N

    LYNN MEDICAL ADULT ECG ELECTRODES 1690-005

    MDR report key: 2721571 · Received August 30, 2012

    Report

    Report Number
    1320894-2012-00059
    Date Received
    August 30, 2012
    Date of Event
    August 2, 2012
    Report Date
    October 24, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K905446
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICES HAVE BEEN DISCARDED BY THE END-USER AND ARE NOT AVAILABLE FOR EVALUATION. PICTURES OF THE DEVICES OR OF THE "SKIN IRRITATION" ARE NOT AVAILABLE. WHEN THE QUALITY ENGINEERING INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUSPECT DEVICES NOT BEING RETURNED.

    Additional Manufacturer Narrative · 1

    THE ACCUSENSOR, LYNN MEDICAL ADULT 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. THE ACCUSENSOR, LYNN MEDICAL ADULT ECG ELECTRODES WERE DISCARDED BY THE END-USER. THE ORIGINAL DEVICES OR PICTURES OF THE DEVICES OR SKIN REACTION WERE NOT AVAILABLE; THEREFORE, AN INVESTIGATION ON THE SUSPECT DEVICE CANNOT BE ACCOMPLISHED. NO PRODUCT WAS RETURNED FOR EVALUATION OR CONFIRMATION OF DEFECT OR CONFIRMATION OF CONMED PRODUCT. DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW COULD NOT BE ACCOMPLISHED AS THE LOT NUMBER OF THE DEVICE WAS NOT AVAILABLE. THE PATIENT SURVEY WAS COMPLETED BY THE ECHO SUPERVISOR OF (B)(6) MEDICAL GROUP AND STATES THAT THE ECG ELECTRODES WERE PROVIDED TO THE END-USER IN A SINGLE ELECTRODE PACKET INCLUDED IN THE HOLTER SET-UP KIT. THESE ECG ELECTRODES WERE UTILIZED BY A LAY USER, WITHIN THEIR HOME, FOR A 24 HOUR HOLTER MONITORING PROCEDURE. THE SURVEY STATED THAT IN REGARDS TO SITE PREPARATION FOR THE ELECTRODES THAT, "A ELECTRODE PREP PAD WAS ENCLOSED IN THE HOLTER SETUP KIT". THE APPLICATION INSTRUCTIONS FOR THIS ECG ELECTRODE ARE PRINTED ON THE ECG POUCH AND STATE, "PREP SITE WITH A BRISK DRY RUB, DO NOT BREAK OR DAMAGE THE SKIN SURFACE". THE SOLUTION FROM THE "ECG PREP PAD" MAY HAVE CAUSE SKIN IRRITATION IF THE SOLUTION FROM THE PAD HAD NOT COMPLETELY DRIED PRIOR TO THE LAY USER OF THE ELECTRODES PLACING THE ECG ELECTRODES ON THE PREPPED SKIN SITES. LACK OF OR IMPROPER SKIN PREPARATION COULD RESULT IN SOLVENTS UNDER THE ELECTRODE SITE SUCH AS SKIN LOTIONS, SKIN SOAP, OR MOIST "ECG PREP PAD" SOLUTION WHICH COULD HAVE CAUSED THE SKIN IRRITATION. RAPID REMOVAL OF THE ECG ELECTRODE FROM THE SKIN COULD ALSO CAUSE SKIN IRRITATION AT THE ECG APPLICATION SITE. THERE COULD BE MULTIPLE OF POSSIBLE CAUSES EITHER MANUFACTURING OR USER RELATED ISSUES FOR THIS FAILURE MODE; HOWEVER, WITHOUT EXAMINATION OF THE ACTUAL DEVICES RELATED TO THIS INCIDENT THE ROOT CAUSES OF THIS EVENT CANNOT BE CONFIRMED. THESE ELECTRODES ARE TESTED AND PASSED FOR BIOCOMPATIBILITY. ALL ECG ELECTRODES MATERIALS ARE TESTED FOR CYTOTOXICITY, SENSITIZATION, AND INTRACUTANEOUS FACTOR PER ISO APPROVED TESTING. IN PROCESS INSPECTION AND VISUAL CHECKS WERE DONE TO ENSURE PROPER PRODUCTION OF THE DEVICES. THE PATIENT MAY HAVE EXPERIENCED AN ALLERGIC RESPONSE TO A COMPONENT OF THE DEVICE SUCH AS ELECTRODE ADHESIVE AND / OR GEL. LIKELY CAUSES OF THIS FAILURE MODE INCLUDE TRAPPED SOLVENTS UNDER THE ECG ELECTRODE DEVICE, RAPID REMOVAL OF THE ECG ELECTRODE, OR, ALLERGIC RESPONSE TO AN ELECTRODE COMPONENT. THE COMPLAINT CANNOT BE CONFIRMED OR UNCONFIRMED AT THIS TIME DUE TO THE LACK OF ACTUAL DEVICES UTILIZED IN THE REPORTED INCIDENT. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED OR CONFIRMED ANY MANUFACTURING DEFECTS ASSOCIATED WITH THE COMPLAINT; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PATIENT COMPLAINED OF IRRITATION ONCE AT HOME AFTER USING ELECTRODES. PT. SELF-TREATED WITH CREAM." PER (B)(6) SURVEY SENT TO (B)(6) THE PATIENT WAS AT HOME FOR A 24-HOUR HOLTER MONITORING. A SINGLE ELECTRODE PACKET WAS INCLUDED IN HOLTER MONITOR SET-UP KIT. THE PATIENT PREPPED SKIN WITH INCLUDED ELECTRODE PREP PAD FROM HOLTER SET-UP KIT. PATIENT DEVELOPED PINK TO RED BUMPS ON CHEST. PATIENT SAW DERMATOLOGIST AND WAS PRESCRIBED A CREAM TO TREAT SKIN IRRITATION (CREAM TYPE / BRAND UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYNN MEDICAL ADULT ECG ELECTRODES 1690-005 ECG ELECTRODES DRX CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other