BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-V ALTERNANS SENSORS

    MDR report key: 1920134 · Received December 8, 2010

    Report

    Report Number
    1225215-2010-00001
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    July 14, 2010
    Report Date
    August 2, 2010
    Manufacturer
    CAMBRIDGE HEART, INC.
    Product Code
    DRX
    PMA / PMN Number
    K002230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE A NEW EXERCISE PHYSIOLOGIST WAS BEING TRAINED ON THE DAY OF THE PATIENT'S TEST, THE PT ENDED UP WEARING THE ELECTRODES FOR APPROX AN HOUR. THIS IS TWICE AS LONG AS THE USUAL 30 MINUTES REQUIRED FOR MTWA TESTING. THE SENSORS USED ON THE PT WERE FRESHLY OPENED (NOT RE-USED) AND DISCARDED AFTER USE. INSPECTION RECORDS FOR LOT #700634 VERIFIED THAT THE SENSORS PASSED INSPECTION.

    Description of Event or Problem · 1

    MTWA TESTING WAS CONDUCTED (B)(6) ON THE PT, WHO COMPLAINED OF A BURNING SENSATION DURING THE TEST. SHE RETURNED A WEEK LATER TO SEEK TREATMENT FOR PERSISTENT SKIN IRRITATION AT THE ELECTRODE SITES. HER CARDIOLOGIST ATTRIBUTED THE MARKS TO THE PT'S EXTREMELY SENSITIVE SKIN AND ADVISED HER TO APPLY ALOE TO THE AFFECTED AREAS. AT A FOLLOW-UP EVALUATION TWO WEEKS AFTER THE TEST, THE PT STILL HAD REDNESS AND SCABBING BUT THE AREAS WERE NOT AS SORE AND APPEARED TO BE IMPROVING. THE CARDIOLOGIST FORWARDED PHOTOS OF THE AFFECTED AREAS TO CAMBRIDGE HEART AND SAID HE WOULD CONTINUE MONITORING THE PT. ON (B)(6), THE PT E-MAILED CAMBRIDGE HEART NOTING THAT SHE BELIEVED THE MARKS WERE PERMANENT. AFTER MAKING SEVERAL ATTEMPTS TO CONTACT THE PT, VIA PHONE AND E-MAIL, CAMBRIDGE HEART (B)(4) SPOKE WITH THE PT ON (B)(6). THE PT REITERATED HER CONCERN THAT THE MARKS MAY BE PERMANENT. HER DESCRIPTION OF THE MARKS AND THE AFFECTED AREAS IS CONSISTENT WITH HYPERPIGMENTATION AT MICRO-V SENSOR SITES FI, V4-V6 AND LL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-V ALTERNANS SENSORS ELECTRODES, ELECTROCARDIOGRAPH DRX CAMBRIDGE HEART, INC. NA 700634

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability