BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 1082223 · Received July 25, 2008

    Report

    Report Number
    2950887-2008-04389
    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 SEPSIS RELATED TO END-STAGE RENAL FAILURE 43 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| IMPLANTED| EXPLANTED