BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1111566 · Received August 13, 2008

    Report

    Report Number
    3004209178-2008-04908
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MPROC, JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    HDE99014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD IMPEDANCE MEASUREMENTS WERE GREATER THAN 4,000 OHMS ON ALL OR SOME OF THE BIPOLAR AND UNIPOLAR PAIRS. THE PT HAD A REVISION AS HER GASTROPARESIS HAD WORSENED. IN THE OPERATING ROOM, ALL THE CONNECTIONS WERE CHECKED AND LOOKED FINE. THE PHYSICIAN REC'D A MESSAGE WITH IMPEDANCES OVER 800; CURRENT WAS 5MA, VOLTAGE WAS NOT REPORTED. FURTHER F/U IS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MPROC, JUNCOS 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL LEAD GES| EXPLANTED