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

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Erosion (1750); Diarrhea (1811); Dysphagia/ Odynophagia (1815); Fatigue (1849); Headache (1880); Myalgia (2238); Hernia (2240); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Weight Changes (2607)

Event Date 01/01/2008

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 435135, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2016, product type: lead, product id: 435135, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2016, product type: lead.

Event Description

The consumer and health care provider (hcp) reported that the patient¿s implantable neurostimulator (ins) worked the first year after they got it, but they were still in pain.The patient was in a severe car wreck in 2008 and after that it was messed up.The patient was doing much better, but after the car wreck, they never knew when they ate if it was going to shoot out or work.The patient went to see their health care provider (hcp) and had to go to physical therapy and they took a cat scan of the machine and it was fine.The patient told their hcp they had pain on the left side.Everyone said the patient was fine.Prior to getting the ins the patient had surgery that caused nerve damage to their stomach nerve that took 4 years to figure out.The hcp asked the patient if they had scar tissue and they said yes.It was thought to likely be related to adhesions given the patient¿s significant surgical history, but no operative interventions were recommended at the time.It did not get better because the one lead was off and the patient was not getting full shock to their digestion.The 3 ¿pumps¿ a minute was not working and the patient lost efficacy.After the car accident the patient was on pain medication until they saw their hcp at the beginning of 2016 and they scoped them, did 9 biopsies, and discovered one of the leads was hanging out of their stomach and the stomach had corrosive black tissue.The patient had an upper gi endoscopy on (b)(6) 2016 due to epigastric abdominal pain.The z-line was irregular and was found 40 cm from the incisors.Biopsies were taken and a small hiatal hernia was present.The duodenum was normal, but 5 cm of the lead had eroded into the lumen of the antrum.Otherwise the stomach was normal.The patient was seen again on (b)(6) 2016 for evaluation of the lead eroding into the stomach.The patient had 3 months of loss of appetite and (b)(6) lbs.Weight loss.The patient denied any significant nausea or vomiting.The patient had left lateral pain in their rectus muscle.The patient had hoarse voice, difficulty swallowing, headaches, muscular pain, indigestion, abdominal pain, loss of appetite, diarrhea, unplanned weight loss, fatigue, and pain at (b)(6).The patient had minimal tenderness on the left side.The patient had a repeat upper endoscopy and there were some eroded leads within the lumen of the stomach.The ins was found to have an intact battery.The hcp could not explain how the erosion of the lead or any malfunctioning of their ins would be causing the point tenderness in their left abdomen.The ins the patient got in 2008 was removed due to corrosive exposed lead issues.The migrated lead was removed and replaced, the other lead was removed and replaced, and the ins was replaced.The ins was programmed.The indication for use for this patient was gastric stimulation.

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: 6136928
• MDR Text Key: 61188380
• Report Number: 3004209178-2016-24932
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2009
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: 11/03/2016
• Supplement Dates FDA Received: 09/27/2017
• Date Device Manufactured: 10/01/2007
• 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): Life Threatening; Required Intervention
• Patient Age: 43 YR