BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 2981004 · Received February 27, 2013

    Report

    Report Number
    3007566237-2013-00613
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 11, 2013
    Report Date
    August 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES WERE REPORTED (890 OHMS) DURING IMPLANTATION PROCEDURE FOR THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM. IT WAS NOTED THAT THE SURGEON "ADMITTED" TO "PROBABLY HANDLING" THE LEADS ROUGHLY DURING THE PLACEMENT AND WAS A CAUSE OF "POSSIBLE MICROFRACTURE" IN THE LEADS. BOTH LEADS WERE REPLACED AND THE NEW LEADS CONNECTED TO THE CURRENT INS BATTERY. THE IMPEDANCE THEN DROPPED TO AN ACCEPTABLE <(><<)>800 OHMS. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE THE PATIENT WAS DOING FINE AND GETTING THERAPEUTIC BENEFIT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83890 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1