BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 4093348 · Received September 16, 2014

    Report

    Report Number
    6000032-2014-00203
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    April 4, 2002
    Report Date
    May 16, 2002
    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).

    Additional Manufacturer Narrative · 1

    CORRECTION: NO ADDITIONAL INFORMATION RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED AFTER A PROLONGED ATTEMPT AT TREATMENT OF HYPOVOLEMIA, NAUSEA, AND VOMITING SECONDARY TO DIABETIC GASTROPARESIS. THE PATIENT ALSO HAD MUNCHAUSEN DISEASE. PRIOR TO ADMISSION, THE PATIENT RECEIVED INTRAVENOUS (IV) THERAPY AT HOME ¿SEVERAL TIMES¿ BUT IT FAILED TO CONTROL THE PATIENT¿S NAUSEA AND VOMITING, SO THE PATIENT AS ADMITTED ON (B)(6) 2002. THE PATIENT CONTINUED TO COMPLAIN OF NAUSEA AND VOMITING, ALTHOUGH THEY APPEARED TO VOMIT ¿FAR LESS¿ THAN OBSERVED. MEDICATION WAS ADMINISTERED INCLUDING IV FLUIDS AND THE FREQUENCY OF THE EPISODES DECLINED GREATLY. THE PATIENT¿S ANTIDEPRESSANTS WERE STOPPED FOR 3 DAYS AND CONCLUDED TO NOT BE CONTRIBUTING TO THE NAUSEA AND VOMITING. ON (B)(6) 2002, THE PATIENT WAS NOTED TO FEEL VERY WEAK AND REPORTED THAT BLOOD SUGAR WAS LOW. FINGERSTICK FOUND CAPILLARY BLOOD GLUCOSE (CB) OF 24. HYPOGLYCEMIA WAS A NON-DEVICE RELATED SYMPTOM SECONDARY TO DIABETES MELLITUS. THIS WAS REMEDIED USING MEDICATION AND BOLUSES OF APPLE JUICE WITH SUGAR MIXED IN. INSULIN PUMP WAS DISCONTINUED WHILE LANTIS INSULIN WAS ADMINISTERED; THE PATIENT'S CBGS WERE IN AN ACCEPTABLE RANGE AT THE TIME OF DISCHARGE. IT WAS STATED THAT EVENT PROVED TO BE EXTREMELY EMOTIONALLY TRAUMATIC AND AS A RESULT HER CBGS RAN IN THE HIGH 500S. DURING THE HOSPITAL STAY, THE PATIENT HAD ¿QUITE ELEVATED¿ BLOOD PRESSURE THAT RESULTED IN ¿SATISFACTORY¿ CONTROL AFTER MEDICATION WAS CHANGED. AT THE TIME OF DISCHARGE, THE PATIENT WAS PHYSICALLY AND EMOTIONALLY STABLE. THE EVENT ENDED ON (B)(6) 2002 AS THE PATIENT RECOVERED FROM THE EVENT 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
    571220 ENTERRA INTESTINAL STIMULATOR LNQ MDT SOFAMOR DANEK PUERTO RICO MFG 7425G

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Hospitalization| R