BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1406106 · Received June 19, 2009

    Report

    Report Number
    2182207-2009-04278
    Event Type
    Injury
    Date Received
    June 19, 2009
    Date of Event
    May 1, 2009
    Report Date
    May 22, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED SEIZURES THE DAY AFTER THEIR DEVICE WAS IMPLANTED. THE PT HAD NO PRIOR HISTORY OF SEIZURES. THE PT WAS IN INTENSIVE CARE UNIT AND WAS INTUBATED. THE PATIENT'S EEG AND CT SCAN WER ENORMAL. THE PT WAS PUT ON ANTI-SEIZURE MEDICATION AND WAS DISCHARGED FROM THE HOSPITAL. FURTHER INFO IS BEGIN REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC NEUROMODULATION 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD: MODEL UNKNOWN| EXPLANTED:| LEAD: MODEL UNKNOWN