BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3111437 · Received May 14, 2013

    Report

    Report Number
    6000032-2013-00123
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    January 24, 2007
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE REMOVED BECAUSE IT WAS ERODING THROUGH THEIR STOMACH. IT WAS NOTED THAT THE PATIENT'S PHYSICIAN WANTED TO REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213385 ENTERRA INTESTINAL STIMULATOR LNQ MDT SOFAMOR DANEK PUERTO RICO MFG 7425G

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention