BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT MAPPING ENSITE¿ NAVX¿ NAVIGATION AND VISUALIZATION, TECHNOLOGY, ENSITE N

    MDR report key: 5707990 · Received June 8, 2016

    Report

    Report Number
    2184149-2016-00006
    Event Type
    Injury
    Date Received
    June 8, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 12, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    549884
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD FOR THE ABOVE-REFERENCED PRODUCT WAS UNABLE TO BE REVIEWED SINCE THE BATCH NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PATIENT BURN OCCURRED. FOLLOWING THE SUCCESSFUL ABLATION, A BURN WAS NOTED ON THE LEFT UPPER BACK OF THE PATIENT. THE BURN WAS SLIGHTLY LARGER THAN A QUARTER, DESCRIBED AS ROUND AND RED WITH A WHITE SKIN TONE AROUND THE BURN, WHICH WAS SLIGHTLY DEEP. THE BURN WAS NOTED AT THE CORNER OF THE ENSITE NAVX PATCH PROXIMAL TO THE SPINE AND THE DISPERSIVE PAD; HOWEVER, NO APPARENT PATCH OVERLAP WAS NOTED. THE PATIENT'S SKIN WAS NOT HAIRY OR DIAPHORETIC DURING THE ABLATION PROCEDURE AND NO SKIN PREPARATION WAS PERFORMED DUE TO THIS. A WOUND SPECIALIST WAS CONSULTED, UNKNOWN TREATMENT WAS ADMINISTERED, AND THE PATIENT HAS SINCE BEEN DISCHARGED. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359886 CONTACT MAPPING ENSITE¿ NAVX¿ NAVIGATION AND VISUALIZATION, TECHNOLOGY, ENSITE N COMPUTER, DIAGNOSTIC PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. EN0010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other