BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 2061779 · Received March 30, 2011

    Report

    Report Number
    3007566237-2011-02398
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE HIGH IMPEDANCES (>4000 OHMS) WERE SEEN ON ONE OF THE LEADS. SPECIFICALLY, BOTH LEADS WERE IMPLANTED (AND ANCHORED) TO THE GREATER CURVATURE OF THE STOMACH AND APPEARED TO BE IN AN ADEQUATE POSITION (10 MM APART). THE HIGH IMPEDANCE MEASUREMENT WAS THEN SEEN WHEN THE LEAD WERE CONNECTED TO THE NEUROSTIMULATOR. THE OTHER IMPLANTED LEAD HAD NORMAL IMPEDANCE MEASUREMENTS. BECAUSE THE SURGEON COULD NOT RELOCATE THE LEAD AS IT WAS ANCHORED IN PLACE, THE LEAD WAS REPLACED. NEW IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL VALUES (547 OHMS). IT WAS ALSO NOTED THAT THE PT HAD A PREVIOUSLY IMPLANTED IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) WHICH WAS CONTINUALLY PACING THROUGHOUT THE PROCEDURE WITH NO INTERFERENCE SEEN BETWEEN THE 2 DEVICES WHEN TESTED INTRA-OPERATIVELY. THE PT RECOVERED W/O SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD: MODEL LEAD GES, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT011737N