BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-V ALTERNANS SENSORS

    MDR report key: 1490147 · Received September 30, 2009

    Report

    Report Number
    1225215-2009-00001
    Event Type
    Injury
    Date Received
    September 30, 2009
    Date of Event
    August 5, 2009
    Report Date
    September 30, 2009
    Manufacturer
    CAMBRIDGE HEART, INC.
    Product Code
    DRX
    PMA / PMN Number
    K002230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    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# 700094 SHOW THAT THE SENSORS PASSED INSPECTION. CAMBRIDGE HEART HOPED TO RETRIEVE UNUSED SENSORS FROM THE LOT FOR EVAL PURPOSES, BUT THE SITE HAD GONE THROUGH ITS ENTIRE CASE OF SENSORS. BECAUSE THE PT EXPERIENCED IRRITATION AT SITES INVOLVING BOTH MICRO-V ALTERNANS SENSORS AND STANDARD ELECTRODES, AGGRESSIVE SKIN PREPARATION MIGHT HAVE BEEN A CONTRIBUTING FACTOR. CAMBRIDGE HEART'S CLINICAL SPECIALIST HAS SINCE RETURNED TO THE CUSTOMER SITE TO PROVIDE ADD'L TRAINING ON SKIN PREPARATION.

    Description of Event or Problem · 1

    THE PT REPORTED A BURNING SENSATION AT SEVERAL ELECTRODE SITES DURING AN 18-MINUTE MICROVOLT T-WAVE ALTERNANS (MTWA) TEST. THE ELECTRODES WERE REMOVED IMMEDIATELY AFTER TESTING (THEY WERE ON FOR APPROXIMATELY 30 MINUTES) AND THE PT SAYS THE BURNING SYMPTOMS AND REDNESS PERSISTED AT FOUR SITES AFTER SHE RETURNED HOME. AMONG THE FOUR SITES WERE TWO STANDARD ELECTRODE SITES (RIGHT ARM AND LEFT ARM) AND TWO MICRO-V SENSOR SITES (H AND V2). WITHIN A DAY, SHE BEGAN APPLYING NEOSPORIN AND TWO DAYS LATER, SHE RETURNED TO THE CARDIOLOGIST'S OFFICE FOR TREATMENT OF THE AFFECTED AREAS. THE DOCTOR PRESCRIBED HYDROCORTISONE 3-4 TIMES A DAY AND AFTER APPROXIMATELY ONE WEEK, THE REDNESS HAD DISSIPATED, BUT HYPERPIGMENTATION OF THE SKIN WAS PRESENT. THE PT RETURNED TO THE DOCTOR, WHO SAW SOME IMPROVEMENT BUT RECOMMENDED THE APPLICATION OF VITAMIN E AND MEDERMA TO RELIEVE THE HYPERPIGMENTATION. SIX WEEKS LATER, THE PT REPORTS THAT SHE IS APPLYING MEDERMA 3-4 TIMES A DAY AND IS SEEING NO IMPROVEMENT IN THE HYPERPIGMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-V ALTERNANS SENSORS ELECTRODE, ELECTROCARDIOGRAPH DRX CAMBRIDGE HEART, INC. NA 700094

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention