BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3922847 · Received July 9, 2014

    Report

    Report Number
    3007566237-2014-01904
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    November 19, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 4351, PRODUCT TYPE: LEAD. PRODUCT ID 4351, PRODUCT TYPE: LEAD. PRODUCT ID 4351, PRODUCT TYPE: LEAD. PRODUCT ID 4351, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE PATIENT REQUIRED REOPERATION FOR A PARTIAL BOWEL OBSTRUCTION WHICH WAS RELATED TO THE INTRA-ABDOMINAL LEADS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET RECEIVED AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE PATIENT REQUIRED REOPERATION FOR A PARTIAL BOWEL OBSTRUCTION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET RECEIVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400064 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R