BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 4093405 · Received September 16, 2014

    Report

    Report Number
    6000032-2014-00205
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    October 19, 2001
    Report Date
    November 18, 2001
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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

    CONCOMITANT PRODUCTS : PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 4301-35, SERIAL # (B)(4), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SEVERE NAUSEA, VOMITING, HEMATEMESIS, ABDOMINAL PAIN, AND GENERAL MALAISE. THESE SYMPTOMS WERE PRESUMED SECONDARY TO HER DIABETIC KETOACIDOSIS AND GASTROPARESIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH NON-DEVICE RELATED SYMPTOMS INCLUDING DIABETIC KETOACIDOSIS AND ¿PROLONGED¿ HYPOGLYCEMIC EVENT IN WHICH SHE EXPERIENCED THE DAY PRIOR TO HOSPITALIZATION. THE PATIENT HAD REPORTEDLY TURNED OFF HER INSULIN PUMP AND HER SUGARS BEGAN TO INCREASE, BUT ONCE THE INSULIN PUMP WAS TURNED BACK ON IT WAS UNABLE TO COUNTERACT THE RESULTING HYPERGLYCEMIA. IT WAS NOTED THAT THE PATIENT HAD A LONG HISTORY OF DIABETES MELLITUS WHICH WAS POORLY CONTROLLED. DIAGNOSTIC TESTS INCLUDED LABORATORY TESTS, BLOOD TESTS, URINALYSIS, AND CHEST X-RAY WHILE MEDICINE ADMINISTERED INCLUDED INTRAVENOUS (IV) FLUIDS, OPIOID ANALGESICS, AND ANTIEMETICS. THE ELECTROCARDIOGRAM REVEALED PEAKED T-WAVES IN THE LATERAL LEADS. THE PATIENT¿S NAUSEA AND VOMITING RESOLVED AS HER KETOACIDOSIS RESOLVED, AND HER DIET WAS ADVANCED UNTIL SHE WAS ABLE TO TOLERATE FULL SOLID FOODS. THE DISCHARGE SUMMARY¿S PRINCIPAL AND FINAL DIAGNOSIS WAS DIABETES MELLITUS TYPE I WITH DIABETIC KETOACIDOSIS. THE EVENT ENDED ON (B)(6) 2001 AS THE PATIENT RECOVERED WITH THERAPEUTIC ACTION. ADDITIONAL FOLLOW-UP IS BEING CONDUCTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570986 ENTERRA INTESTINAL STIMULATOR LNQ MDT SOFAMOR DANEK PUERTO RICO MFG 7425G

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Hospitalization| R