BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2404741 · Received January 9, 2012

    Report

    Report Number
    3004209178-2012-00156
    Event Type
    Injury
    Date Received
    January 9, 2012
    Report Date
    December 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL H990014, (B)(4), IMPLANTED: 2011 (B)(4), EXPLANTED: UNKNOWN, LEAD MODEL H990014, (B)(4), IMPLANTED: 2011 (B)(4), EXPLANTED: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RETURN OF SYMPTOMS AND PLACED ON A FEEDING TUBE. IT IS UNKNOWN IF THE NEUROSTIMULATOR WAS ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA INTESTINAL STIMULATOR LNQ MDT PUERTO RICO OPERATIONS CO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention