BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 1082229 · Received July 25, 2008

    Report

    Report Number
    2950887-2008-04388
    Event Type
    Death
    Date Received
    July 25, 2008
    Report Date
    February 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    LITERATURE ARTICLE: LIN Z, ET AL. SYMPTOM RESPONSES, LONG-TERM OUTCOMES AND ADVERSE EVENTS BEYOND 3 YEARS OF HIGH-FREQUENCY GASTRIC ELECTRICAL STIMULATION FOR GASTROPARESIS. NEUROGASTROENTEROL MOTIL 2006; 18:18-27. THE STUDY INCLUDED 55 PTS WITH REFRACTORY GASTROPARESIS IMPLANTED WITH A GASTRIC ELECTRICAL STIMULATION (GES) SYSTEM FOR AT LEAST 3 YEARS WHO UNDERWENT GES IMPLANTATION FROM APRIL 1999 TO OCT. 2001. ONE PT DIED FROM ASPIRATION PNEUMONIA NINE MONTHS AFTER SURGERY. IT WAS REPORTED THE CAUSE OF DEATH WAS UNRELATED TO THE GES THERAPY; THE PT DIED OF NON-PACEMAKER RELATED COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GASTRIC LEAD MODEL UNK LOT # UNK| EXPLANTED| IMPLANTED