BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1097523 · Received July 25, 2008

    Report

    Report Number
    2182207-2008-04239
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    May 25, 2005
    Report Date
    June 1, 2005
    Manufacturer
    MEDTRONIC, INC. NEUROLOGICAL DIV.
    Product Code
    EZW
    PMA / PMN Number
    HDE990017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION WHICH COVERS A TWO YR TIME PERIOD FROM JUNE 1, 2005 TO MAY 30, 2007 FOR PREVIOUSLY UNREPORTED MEDICAL DEVICE REPORTS FOR MEDTRONIC GASTROLOGICAL AND UROLOGICAL (MGU) PRODUCT COMPLAINT REPORTS. THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 11 UNREPORTED MALFUNCTION EVENTS FOR MODEL 3116 AND 4 UNREPORTED MALFUNCTION EVENTS FOR MODEL 4351; ALL PRODUCT CODE LNQ). THIS TOTAL INCLUDES THE EVENT DESCRIBED IN THIS REPORT. (SEE THE ATTACHED SUMMARY REPORT FOR A LISTING OF ALL EVENTS).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A SHOCKING SENSATION OVER THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA EZW MEDTRONIC, INC. NEUROLOGICAL DIV. 4351 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention EXPLANTED| IMPLANTABLE PULSE GENERATOR MODEL 3116 | IMPLANTED| LOT # NHV100593H| IMPLANTED| EXPLANTED| LOT # NHV100593H| IMPLANTABLE PULSE GENERATOR MODEL 3116