BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3922912 · Received July 9, 2014

    Report

    Report Number
    3007566237-2014-01908
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    February 25, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: INITIAL MEDWATCH WAS SUBMITTED IN ERROR AND IS BEING REDACTED. UPON FURTHER REVIEW, EVENT WAS DETERMINED TO NOT BE REPORTABLE. THERE WAS NO CLARIFICATION ON THE SAES, SO DOES NOT MEET REQUIREMENTS FOR REPORTING FOR SERIOUS INJURY AS DEFINITION OF SAE MAY NOT BE THE SAME AS THE DEFINITION OF SERIOUS INJURY FOR MEDTRONIC. FURTHERMORE, NO INDICATION OR REPORT OF PERMANENT IMPAIRMENT, MEDICAL/SURGICAL INTERVENTION, OR HOSPITALIZATION. REQUESTING FOLLOW UP FOR FURTHER CLARIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 75 SERIOUS ADVERSE EVENTS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET RECEIVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399453 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention