BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1031196 · Received April 18, 2008

    Report

    Report Number
    2182207-2008-02049
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    HDE990017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE PT'S ENTERRA LEADS MIGRATED AND WRAPPED AROUND THE SMALL BOWEL, CAUSING AN OBSTRUCTION. BOTH LEADS WERE CUT BACK TO THE STOMACH WALL WHICH RELIEVED THE OBSTRUCTION. THE IPG AND CUT LEADS WERE THEN EXPLANTED. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC NEUROMODULATION 4351 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R LEAD MODEL 4351| IMPLANTABLE PULSE GENERATOR MODEL 3116| LOT # NHV101984H| EXPLANTED: