BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 4170497 · Received October 14, 2014

    Report

    Report Number
    3007566237-2014-02968
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    February 24, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 4351, SERIAL # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 4351, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: SAME EVENT REPORTED IN MANUFACTURER REPORT # 6000032-2005-00907. FILES BEING MERGED. HOWEVER, REPORT IS NOT BEING REDACTED AS THIS REPORT STILL CONTAINED INFORMATION THAT WAS NOT PREVIOUSLY REPORTED IN REPORT # 6000032-2005-00907. ANY ADDITIONAL INFORMATION RECEIVED WILL BE UPDATED IN SUPPLEMENTAL REPORTS OF 6000032-2005-00907.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD (B)(6) SO THE DEVICE WAS REMOVED AND LATER RE-IMPLANTED. CAUSE, DATES, PRIOR MEDICAL STATUS, CLINICAL COURSE, TREATMENTS, AND FINAL OUTCOME WERE NOT REPORTED. ADDITIONAL FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651444 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention