BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 4192525 · Received October 22, 2014

    Report

    Report Number
    3007566237-2014-03069
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT REQUIRED STIMULATOR EXCHANGE FOR DEVICE FAILURE. NO OUTCOME WAS NOTED AT THE TIME OF REPORT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672362 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention