MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Cellulitis (1768); Deposits (1809); Edema (1820); Erythema (1840); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Paresis (1998); Swelling (2091); Tachycardia (2095); Thrombosis (2100); Urinary Tract Infection (2120); Vomiting (2144); Distress (2329); Discomfort (2330); Fracture, Arm (2351); Laceration(s) of Esophagus (2398); Fungal Infection (2419); No Code Available (3191); Constipation (3274)

Event Date 05/02/2003

Event Type  Injury  

Manufacturer Narrative

Concomitant product: product id 4351, serial# unknown, product type lead; product id 4351, serial# unknown, product type lead.(b)(4).

Event Description

It was reported that the patient was admitted to the hospital twice for diabetic gastroparesis, nausea, and vomiting.On (b)(6) 2003, the patient was first admitted to the hospital complaining of nausea and vomiting over the previous 3-4 days.Upon admission, the patient had arterial blood gas (abg) above abnormality, was "not able to keep any food down," noticed "some bile in her vomiting," complained of epigastric pain, and had not had a bowel movement in three days.Physical examination determined that the patient had mild distress, tachycardic resting heart rate of 109 beats per minute, mild tenderness of abdomen mainly in the epigastric area, hyperactive bowel sounds, and elevated blood pressure of 145/96.Spiral ct was performed to rule out pulmonary embolism as abg showed hypoxia with carbon dioxide retention; the ct was negative for pulmonary embolism and it was suggested that abg was "most likely" secondary to hypoventilation secondary to narcotics.Medication was administered and the patient "gradually improved but she continued to complain of nausea." during hospitalization, the patient developed right upper extremity swelling with pain, erythema, and tenderness, and was soon diagnosed with cellulitis.Antibiotics were initially administered but the patient's swelling continued to increase.Improvement was achieved with swelling once the antibiotics were switched to unasyn.An x-ray of the patient's right upper extremity showed soft tissue edema and nondisplaced ulnar fracture.The orthopedic surgeon stated that they did "not feel strongly about the fracture because there was no history of trauma and they think it was mostly her cellulitis." compression garment and physical therapy was recommended in which the patient improved gradually.The patient reportedly developed a urinary tract infection as well, but urine cultures came back negative and her urine showed trichomonas, in which she was treated with flagyl intravenously for two days.An esophagogastroduodenoscopy was performed and showed severe esophageal candida throughout the esophagus; multiple thick white exudative plaques were present and were subsequently removed which caused punctuate mucosal bleeding.A large adherent blood clot was found in the distal esophagus most likely from prior mallory-weiss tear.A large portion of the clot was irrigated away, revealing grade ii erosive esophagitis.The esophageal candida was treated with medication.Non-device related symptoms and conditions included mild diabetic ketoacidosis which resolved after fluids and insulin.It was noted that patient was admitted through (b)(6) 2003, but then it later stated that the patient was discharged on (b)(6) 2003.The next day following discharge, the patient reportedly started to complain of left lower extremity swelling with pain, nausea, and vomiting, noting she was unable to keep any food down with epigastric pain.The patient was then admitted to the hospital from (b)(6) 2003.Diagnostic procedures included esophagogastroduodenoscopy and ultrasound, which showed esophageal candidiasis and deep venous thrombosis on left lower extremity, respectively.Medication was administered and the patient's laboratory results were closely monitored.A duplex doppler examination was performed of the deep venous systems of the bilateral lower extremities which was a "somewhat limited exam" that found that there was no definite evidence of a lower extremity deep vein thrombosis and right inguinal lymph node may be reactive or neoplastic, recommending clinical correlation.The patient had elevated blood pressure and complained of constipation which improved with medication.The patient's nausea and vomiting started to improve as a result of the medication, but the patient still continued to complain of mild nausea.The patient also had non-device related symptoms and conditions including diabetes and the associated high glucose; her glucose was improved with insulin and she continued to be weak during her hospitalization.The event resolved on (b)(6) 2003 where the patient recovered from event with therapeutic action.Additional follow-up is being conducted.If any additional information is received, a supplemental report will be sent.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4095812
• MDR Text Key: 19371499
• Report Number: 3007566237-2014-02602
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2003

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention