BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD 4351M IS-1 GASTRIC STIMULATION

    MDR report key: 3103176 · Received May 9, 2013

    Report

    Report Number
    6000030-2013-00111
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 4351M, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES WERE OUT OF RANGE. IT WAS NOTED THAT THE SYSTEM WAS VERIFIED FOR FUNCTIONALITY AFTER THE LEADS WERE IMPLANTED IN THE STOMACH WALL AND CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS). WHEN INTERROGATING THE DEVICE, IMPEDANCES WERE MEASURED AT 292 OHMS, WHICH WAS BELOW THE EXPECTED RANGE OF 300 TO 1200 OHMS. THE DEVICE AND LEADS FUNCTIONED AS EXPECTED, BUT THE IMPEDANCE WAS OUT OF RANGE FROM THAT IN THE PROTOCOL. IT WAS NOTED THAT THE "DECISION IN THE OPERATING ROOM WAS TO LEAVE THE DEVICE IMPLANTED WITHOUT MODIFICATIONS TO THE DEVICE OR LEADS." IT WAS NOTED THAT THE SITE WOULD CONTINUE TO MONITOR THE IMPEDANCE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204137 LEAD 4351M IS-1 GASTRIC STIMULATION INTESTINAL STIMULATOR LNQ RICE CREEK MFG 4351M

    Patients

    Seq Age Sex Outcome Treatment
    1