MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Sleep Dysfunction (2517); Electric Shock (2554); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer (con) via a healthcare professional (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient hadn¿t done anything with their device and they were in constant pain and shocking.Also, when they were in the shower and would bend over to wash their feet, it felt like it would dislodge and they would have to stand up and arch their back to get it to pop back into place.The patient was scheduled to see a new hcp in september and they wanted the device to be turned off.It was noted that these issues started 3-4 years prior, but started as intermittent; only 1-2 per month.This progressed to weekly, daily, and, at the time of the report, it was constant.The patient hadn¿t slept in nine days.It was noted that the patient¿s device was firing constantly.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the healthcare professional (hcp) on october 16th reported the patient was experiencing severe pain, shock-like feeling in their body and believed the device should have been replaced in 2012.The hcp stated the patient had been trying to get the device removed for the last 2 years.The hcp noted multiple imaging modalities had been used and the patient implanted system was not showing up on the imaging.The hcp stated the system was implanted in 2007.The hcp stated this issue started ¿several years ago¿.Additional information from a friend or family member on october 16th reported the patient had the implant in 2007 and did not have a follow up after the implant.The caller stated the patient was experiencing symptoms such as sharp like pain, insomnia, and muscle spasms and wanted the device removed.The caller stated through x-ray film the device was not viewable.It was noted the caller stated the patient suffered daily.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7722408
• MDR Text Key: 115394415
• Report Number: 3007566237-2018-02219
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1