BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 4170311 · Received October 14, 2014

    Report

    Report Number
    3007566237-2014-02961
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    November 18, 2002
    Report Date
    November 20, 2002
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD BROKE PRIOR TO PATIENT IMPLANTATION. CAUSE AND ANALYSIS WAS NOT GIVEN. ADDITIONAL INFORMATION IS BEING CONDUCTED TO OBTAIN THESE ANSWERS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649167 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 4351

    Patients

    Seq Age Sex Outcome Treatment
    1