BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000030-2015-00147

    MDR report key: 5132777 · Received October 7, 2015

    Report

    Report Number
    6000030-2015-00147
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 2015
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH THE EXTERNAL PULSE GENERATOR (EPG) PATIENT CABLE. FOLLOW UP INDICATED THAT THE INCIDENT INVOLVED DIFFICULTY WITH THE EPG. A NEW CABLE WAS SUCCESSFULLY USED. THE CABLE IS EXPECTED TO BE RETURNED. THE EPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662597 DTE RICE CREEK MFG EPG-MEDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention