BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 4090476 · Received September 15, 2014

    Report

    Report Number
    6000032-2014-00201
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    February 13, 2002
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 4301-35, SERIAL# (B)(4), PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF URINARY TRACT INFECTIONS (UTI). DATES, CAUSES, CLINICAL TREATMENT, AND OUTCOME WERE NOT GIVEN. ADDITIONAL FOLLOW-UP IS BEING CONDUCTED TO DETERMINE THOSE ANSWERS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570289 ENTERRA INTESTINAL STIMULATOR LNQ MDT SOFAMOR DANEK PUERTO RICO MFG 7425G

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention