BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-V ALTERNANS SENSORS

    MDR report key: 974748 · Received December 31, 2007

    Report

    Report Number
    1225215-2007-00002
    Event Type
    Injury
    Date Received
    December 31, 2007
    Date of Event
    July 20, 2007
    Report Date
    December 31, 2007
    Manufacturer
    CAMBRIDGE HEART, INC.
    Product Code
    DRX
    PMA / PMN Number
    K002230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION RECORDS FOR LOT #542791 SHOW THAT THE SENSORS PASSED INSPECTION. WE WILL FILE AN UPDATED REPORT WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    10/22/07: CARDIOVASCULAR TECHNICIAN ASKED CAMBRIGDGE HEART FOR A LIST OF ALTERNANS SENSOR GEL COMPONENTS BECAUSE 4 OF APPROX 130 PTS HAD REPORTED RED WELTS AFTER MICROVOLT T-WAVE ALTERNANS TESTING. TECH SAID NONE OF THE PTS HAD SOUGHT ADDITIONAL TREATMENT. HE WAS ADVISED NOT TO OVER-ABRADE THE PTS' SKIN. ON 11/2/07: ALTHOUGH THE COMPONENT LIST WAS FAXED TO TECH, HE PHONED TO SAY HE HAD NOT RECEIVED IT. HE ALSO SAID, HE HAD TAKEN THE ADVICE REGARDING ABRASION AND THAT SKIN IRRITATION WAS LESS COMMON. HOWEVER, A CARDIOLOGIST AT THE SITE, STATED THAT THE DAY BEFORE, A PT RETURNING FOR FOLLOW-UP AFTER A 4-MONTH EARLIER, MTWA TEST HAD RED MARKINGS THAT HER DOCTOR CLASSIFIED AS PERMANENT SCARS. HE REQUESTED THAT A CAMBRIDGE HEART REP BE SENT TO THE SITE. ON 12/7/07: A CAMBRIDGE HEART EMPLOYEE MET WITH DR. AND LEARNED THAT THE PT, A LIGHT-SKINNED AFRICAN AMERICAN WITH NO KNOWN ALLERGIES OR OTHER MEDICAL ISSUES, HAD THE SENSORS ON FOR NO MORE THAN AN HOUR. DR. SAID, HE OBSERVED AN AREA OF HYPERPIGMENTATION AT THE TOP OF HER BREASTBONE AND REFERRED HER TO A DERMATOLOGIST. BASED ON THE INFO RECEIVED DURING THIS VISIT, CAMBRIDGE HEART DETERMINED THAT THIS IS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-V ALTERNANS SENSORS ELECTORDE, ELECTROCARDIOGRAPH DRX CAMBRIDGE HEART, INC. NA 542791

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention