BEUDAMED
    FDA Adverse Event Summary report: N

    MICRO-V ALTERNANS SENSORS

    MDR report key: 2261429 · Received September 21, 2011

    Report

    Report Number
    1225215-2011-00002
    Date Received
    September 21, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 25, 2011
    Manufacturer
    CAMBRIDGE HEART, INC.
    Product Code
    DRX
    PMA / PMN Number
    K002230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SENSORS USED ON THE PT WERE FRESHLY OPENED (NOT RE-USED) AND DISCARDED AFTER USE. INSPECTION RECORDS FOR LOT 578737005 VERIFIED THAT THE SENSORS PASSED INSPECTION. AS OF (B)(6), THE SITE HAD CONDUCTED 29 MORE (B)(6) TESTS WITH NO ADVERSE EVENTS REPORTED. SOME OF THESE PTS WERE TESTED WITH SENSORS FROM THE SAME LOT AS THOSE USED ON THE AFFECTED PT.

    Description of Event or Problem · 1

    PT WORE MICRO-V ALTERNANS SENSORS ALONG WITH STANDARD ELECTRODES FOR 20-25 MINUTES ON (B)(6) DURING AN (B)(6) TEST. SHE WAS PREPPED BY AN EXPERIENCED TECHNICIAN USING 3M TAPE, AND THE PHYSICIAN ASSISTANT REPORTS NOTHING UNUSUAL ABOUT THE PT PREP OR THE TEST. ON (B)(6), THE PT WENT TO HER DERMATOLOGIST AND WAS DIAGNOSED WITH CONTACT DERMATITIS AT SEVERAL ELECTRODE SITES (INCLUDING BOTH STANDARD AND MICRO-V SENSOR SITES). THE DERMATOLOGIST PRESCRIBED HIGH POTENCY TOPICAL CORTICOSTEROIDS. ON (B)(6), THE PT RETURNED TO HER CARDIOLOGIST, WHO REPORTED THAT THE IRRITATION "HAD SUBSIDED ALMOST COMPLETELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-V ALTERNANS SENSORS ELECTRODE, ELECTROCARDIOGRAPH DRX CAMBRIDGE HEART, INC. NA 578737005

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention