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 Pyrosis/Heartburn (1883); Pain (1994); Vomiting (2144); Weakness (2145); Discomfort (2330); Weight Changes (2607); No Code Available (3191); Constipation (3274)

Event Date 05/13/2003

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital for malnutrition.Symptoms included increased nausea, increased vomiting, hematemesis, bloody diarrhea, heartburn, intermittent constipation, weakness, pain, and 25-pound weight loss.Colonoscopy and es ophagogastroduodenoscopy were done approximately 2 weeks prior and were negative.Laboratory results were unremarkable.Physical examination discovered tender abdomen in the right lower quadrant, decreased bowel sounds, and wasted peripheral muscles.Other non-device related symptoms included decreased sensation in bilateral lower extremities, mild diabetic ketoacidosis (dka), and chronic pain secondary to diabetic peripheral neuropathy.The patient had multiple medications administered, including antiemetics.It was noted that the diarrhea and blood in the stool had resolved while the pain was moderately controlled during hospitalization.The patient was "somnolent" at some point during hospitalization.Tube feedings were given to the patient who never developed nausea or vomiting with it.Dka resolved after the patient was given intraveous (iv) fluids and increase in medication.On the day of discharge, the patient was feeling well, his tube feeds were titrated up to their goal rates, and his fingersticks were in good control.The event ended on (b)(6)-2003 as the patient recovered from the event with therapeutic action.Additional follow-up was requested.If any additional information is received, a supplemental report will be sent.

Manufacturer Narrative

(b)(4).

• 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: 4090273
• MDR Text Key: 4746131
• Report Number: 3007566237-2014-02590
• 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

• 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
• Initial Date Manufacturer Received: 06/11/2003
• Initial Date FDA Received: 09/15/2014
• 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