BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-V ALTERNANS SENSORS

    MDR report key: 909457 · Received September 10, 2007

    Report

    Report Number
    1225215-2007-00001
    Event Type
    Injury
    Date Received
    September 10, 2007
    Date of Event
    July 9, 2007
    Report Date
    July 16, 2007
    Manufacturer
    CAMBRIDGE HEART, INC.
    Product Code
    DRX
    PMA / PMN Number
    K002230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SENSORS USED ON THE PATIENT WERE FRESHLY OPENED (NOT RE-USED) AND DISCARDED AFTER USE. INSPECTION RECORDS FOR LOT #542984 SHOW THAT THE SENSORS PASSED INSPECTION. (SEE ATTACHED). CAMBRIDGE HEART ATTEMPTED TO RETRIEVE THE UNUSED SENSORS FOR EVALUATION, BUT THE SITE HAS DISCARDED THEM. (SEE ADD'L SCANNED PAGES.)

    Description of Event or Problem · 1

    SUBJECT WAS ON THE TREADMILL FOR NO MORE THAN 45 MINUTES DURING A T-WAVE ALTERNANS TEST. WHEN THE SENSORS WERE REMOVED IMMEDIATELY AFTER THE TEST, "BLOOD-RED" IMPRINTS OF THE SENSORS WERE CLEARLY VISIBLE ON HIS SKIN. THE NURSE PRACTIONER- WHO CONDUCTS THE MTWA TESTS AFTER HER ASSISTANT HAS PREPPED THE PATIENTS - SAID SHE WAS CONCERNED BECAUSE THE IRRITATED SPOTS LOOKED LIKE CHEMICAL BURNS. ALSO, BECAUSE THIS PARTICULAR PATIENT IS LEUKOPENIC (LACKING A NORMAL NUMBER OF WHITE CELLS), SHE WANTED TO ENSURE THAT HE WOULD NOT SUCCUMB TO INFECTION. SHE RECOMMENDED AN OVER-THE-COUNTER OINTMENT (NEOSPORIN) AND ADVISED THE PATIENT TO KEEP THE AFFECTED AREAS CLEAN AND DRY. SHE ALSO INSTRUCTED HIM TO CALL HER IF THE IRRITATION DID NOT RESPOND TO THE OINTMENT. WHEN THE PATIENT PHONED THE NEXT DAY TO REPORT THAT THE NEOSPORIN WAS NOT WORKING, THE NURSE PRACTITIONER PRESCRIBED BACTROBAN, A TOPICAL ANTIBIOTIC OINTMENT. A FEW DAYS LATER THE PATIENT CALLED TO SAY THE IRRITATED AREA WAS CLEARING UP NICELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-V ALTERNANS SENSORS ELECTRODE, ELECTROCARDIOGRAPH DRX CAMBRIDGE HEART, INC. NA 542984

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention