BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1885178 · Received October 25, 2010

    Report

    Report Number
    3007566237-2010-08402
    Event Type
    Injury
    Date Received
    October 25, 2010
    Report Date
    September 10, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUTURE DISC ON THE INSIDE OF THE PT'S STOMACH WAS OBSERVED UNDER ENDOSCOPY. THE DISC, WHICH WAS SUPPOSED TO BE ON THE SEROSAL SURFACE OF THE STOMACH, HAD MIGRATED INWARDS. IMPEDANCE LEVELS WERE NORMAL. THE "HW" WAS EXPLANTED. IMAGES WERE TAKEN, BUT NO RESULTS WERE GIVEN. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC NEUROMODULATION 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL LEAD GES, LOT # UNK| LEAD: MODEL LEAD GES, LOT # UNK| EXPLANTED: