MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Fatigue (1849); Headache (1880); Pyrosis/Heartburn (1883); Muscle Weakness (1967); Nausea (1970); Paresis (1998); Swelling (2091); Vomiting (2144); Burning Sensation (2146); Hernia (2240); Discomfort (2330); Complaint, Ill-Defined (2331); Neck Pain (2433); Prolapse (2475); Abdominal Cramps (2543); Weight Changes (2607)

Event Date 04/07/2014

Event Type  Injury  

Event Description

Information received from a healthcare provider for a clinical study, via a manufacturing representative, reported that the patient presented to the e.R.On (b)(6) 2014 complaining of abdominal pain in the left lower quadrant and the symptoms began 4 days prior.The symptoms did not radiate.The patient had nausea and vomiting and the symptoms were crampy and sharp.At its worst, the pain was moderate.The patient had experienced similar episodes in the past, multiple times.The patient had a history of chronic abdominal pain with multiple stimulators in place.The patient was seen the day prior and they did a full workup that was negative.The pain persisted and the patient saw their hcp for a barium swallow.On (b)(6) 2014, the patient went to the e.R.Again and the pain felt like appendicitis.The patient had been in the e.R.4 times this week.The symptoms were unchanged despite home interventions.The patient appeared uncomfortable and the hcp asked for a ct scan.The problem was an acute exacerbation.On (b)(6) 2014, the patient presented to the e.R.Again for abdominal pain and had nausea, vomiting, decreased appetite, and anorexia.The symptoms became worse on (b)(6) 2014 and the patient believed their hiatal hernia was back and that was the reason for their symptoms.The possible causes were unknown.The symptoms were aggravated by food and were described as achy.The pain at its worst was severe.On 2014-04-23, the patient came back to the er with abdominal pain in the upper abdomen and had diarrhea.The symptoms were described as burning, constant, and sharp.The patient had a ct of the abdomen and pelvis and it showed hiatal hernia and no other cause of the symptoms.The patient had a gastric emptying study planned for next week.This was typical pain, but it became unbearable on the evening of (b)(6) 2014.The patient had mild abdominal tenderness in the epigastric area and rebound tenderness in the right and left upper quadrants.The gastric emptying study showed a slightly delayed time-course of gastric emptying, suggestive of gastroparesis.On (b)(6) 2014, the patient went to the er with abdominal pain in the lower abdomen.The patient also had burning in the esophagus and heartburn.The patient had been taking medication with no relief.The patient's last bowel movement was earlier in the day and it was runny, which was typical for them.The pain had become too severe, prompting the visit.On (b)(6) 2014, the patient had malnutrition after their j-tube fell out last night.The j-tube was exchanged.On (b)(6) 2014, the patient had rectal bleeding from hemorrhoids, rectal prolapse, and mucosal prolapse.The patient had transrectal excision of the rectal prolapse.There were no complications with the procedure.The patient had an upper gi endoscopy on (b)(6) 2014.The patient had trouble swallowing.The patient was there for endoscopy and dilation of likely recurrent peptic structure.The patient had increased epigastric pain.The examined esophagus was normal and there was mild torsion of the esophagus at the ge junction.There was no mucosal defect seen and evidence of a roux-en-y gastrojejunostomy was found.There was a small amount of food present in the very small gastric pouch.The anastomosis had healthy looking mucosa.The patient had gerd and hiatal hernia and developed dysphagia.On (b)(6) 2014, the patient had evaluation of their j-tube.The tube came out at home and the patient replaced it, but they had pain.Single view of the abdomen confirmed good positioning of the j-tube.There was no evidence of extravasation into the peritoneum.On (b)(6) 2015, the patient had malnutrition after their j-tube fell out about 6 days ago.The j-tube was replaced.The patient was having a lot of issues with tube feedings and foods that she could eat.The patient had nausea alone diagnosed on (b)(6) 2015.During the healthcare visit on (b)(6) 2015, the patient had symptoms including fatigue, headaches, muscle weakness, enlarged neck due to goiter, and recent weight loss.The patient had an office visit on (b)(6) 2015 and noted they had a gastric tube after the gastrectomy and was feeding by tube only.The patient appeared to be under more stress.The patient complained of a change in appetite, fatigue, weakness, and weight loss.On (b)(6) 2015, a single view of the abdomen demonstrated no dilated loops of bowel to suggest bowel obstruction.Stool was identified in the left colon.Stable positioning of the surgical clips were identified in the upper left quadrant right mid-abdomen.A j-tube was in place and the implantable device projecting over the left pelvis was stable.The patient had an office visit on (b)(6) 2015 and complained of chronic pain, their joints were hurting bad, and they had left sided abdominal pain.There was nothing to fix structurally, they would just have to manage it.On (b)(6) 2015, an axial ct scan of the abdomen was performed due to the patient having abdominal pain.Ct evaluation of the abdomen revealed that the colon was distended with a large volume of stool within the colon compatible with constipation.Few calcifications were noted within the fundus of the uterus suggestive of uterine fibroids, small in size.No small bowel obstruction was noted.The patient had a clogged j-tube on (b)(6) 2015 and had gastroparesis and malnutrition.The patient went to the hospital to exchange the j-tube.The patient hadn't had their medications yet as a result of tube malfunction.On (b)(6) 2015, the patient had an office visit and discussed chills, fever, blackouts, and falls for 12 days now.The patient felt bad, had their feeding tube clogged, and was without medication for 5 days.The patient had cramps as well.The patient had unchanged cachexia since (b)(6) 2015.A biopsy of soft tissue was requested on (b)(6) 2016 when the patient had a hemorrhoidectomy and the diagnosis was early mucosal prolapse.The patient had an office visit on (b)(6) 2016 and mentioned having a gastric resection for gastroparesis.The patient had vomiting and heartburn since having a hiatal hernia repair.The patient had a very tender rectal exam.The patient had a proctoscopy and had left anterior prolapsing rectal tissue noted.The patient's current problems included internal hemorrhoids, hypoglycemia, weight loss, blackout, chills, vitamin d deficiency, abdominal pain, bleeding anal or rectal, chronic diarrhea, constipation, weakness on the left side of the body, neck pain, osteoarthritis, hypertension, migraine, depression/anxiety, malnutrition, chronic pain syndrome, irritable bowel syndrome (ibs), and incontinence.The patient had transrectal repair of rectal mucosal prolapse transrectally on (b)(6) 2016.The patient presented and underwent the procedure without complication and was discharged the same day in good condition.The patient was in the hcp's office for post-op hemorrhoidectomy on (b)(6) 2016.The patient's prolapse was unchanged and was still sore and they had anal or rectal pain.The patient had some external/anal canal swelling.The indication for use for this patient was gastric stimulation.Past medical history included dysphagia, allergies or hay fever, anemia, ankle swelling, asthma, black or tarry bowel movements, excessive bleeding after cuts, blood in stool, blurring of vision, bronchitis, easy bruising, buzzing or ringing in ears, chest colds lasting at least 3 weeks, chest pain, chest pain which radiated down arm, chronic cough, colds usually going to the chest, colitis, coughing up blood, diarrhea lasting more than one week, excessive gas or bloating, feeling too hot or too cold, frequent backaches, frequent headaches, frequent nausea or vomiting, getting up at night to urinate, hemorrhoids, hepatitis or other liver disease, hernia, hoarseness that lasted more than a week, hypertension, intolerance of fatty foods, jaundice, kidney stones, loss of force when you urinate, migraine headaches, pain in either leg on walking, pain or inflammation in eyes, persistent numbness in any body part, pneumonia, recent change in bowel habits, short of breath walking at normal pace, stomach pain, sudden attacks of dizziness or faintness, swelling or lumps, tremors or shaking of hands, and wheezy or whistling chest.The patient also had a medical history of anxiety disorder, copd, depression, gastroesophageal reflux disease, osteoarthritis, peptic ulcer disease, irritable bowel, shingles, spastic colon syndrome, and fatigue.Past operations included appendectomy, tubal ligation, breast augmentation, diatle, hernia repair, cholecystectomy, tonsillectomy, bowel stimulator placement, gastric stimulator placement, and 3 feeding tube replacements.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5937614
• MDR Text Key: 54263936
• Report Number: 3004209178-2016-18544
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• Date Device Manufactured: 08/29/2012
• 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): Required Intervention
• Patient Age: 48 YR