BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1000108 · Received February 19, 2008

    Report

    Report Number
    2182207-2008-00775
    Event Type
    Injury
    Date Received
    February 19, 2008
    Report Date
    February 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    HDE990017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: LIU ET AL. "EROSION OF GASTRIC ELECTRICAL STIMULATOR ELECTRODES: EVALUATION, MANAGEMENTS, AND LAPAROSCOPIC TECHNIQUES." SURG LAPAROSC ENDOSC PERCUTAN TECH 2007; 17(5): 438-441. THIS ARTICLE DESCRIBES TWO CASE REPORTS OF PTS WITH DIABETIC GASTROPARESIS THAT WERE TREATED WITH GASTRIC STIMULATOR AND HAD ELECTRODE EROSION. REPORTABLE EVENT: A MAN WITH DIABETIC GASTROPARESIS UNDERWENT LAPAROSCOPIC PLACEMENT OF A GASTRIC STIMULATOR WITHOUT COMPLICATION. HE REQUIRED READMISSION POSTOPERATIVE DAY 4 FOR NAUSEA, VOMITING, AND SIGNIFICANT PAIN AT THE STIMULATOR POCKET SITE. ABDOMINAL CT AND EDG FAILED TO DEMONSTRATE ANY ABSCESSES OR ELECTRODE EROSION THROUGH THE GASTRIC WALL. THE PT WAS GIVEN ANTIBIOTICS FOR POSSIBLE HARDWARE INFECTION AND SYMPTOMS IMPROVED. AFTER DISCHARGE, THE PT COMPLAINED OF PERSISTENT GASTRIC STIMULATOR SITE PAIN. SIXTEEN MONTHS POST IMPLANT THE PT PRESENTED WITH POCKET INFECTION THAT DID NOT RESOLVE WITH ANTIBIOTICS AND WOUND CARE. THE PT WAS CONSENTED FOR DEVICE REMOVAL AND DURING SURGERY IT APPEARED THAT BOTH ELECTRODES HAD ERODED THROUGH A SINGLE POINT IN THE GASTRIC WALL. THE DEVICE AND 2 ELECTRODES WERE REMOVED AND THE SUBJECT RECOVERED WELL FROM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA EZW MEDTRONIC NEUROMODULATION 4351 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention PROGRAMMER MODEL UNK| IMPLANTABLE PULSE GENERATOR MODEL 3116