MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Nausea (1970); Occlusion (1984); Pain (1994); Therapeutic Effects, Unexpected (2099); Stenosis (2263); Obstruction/Occlusion (2422); Electric Shock (2554)

Event Date 05/01/2015

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The patient reported that they had their devices removed and wanted to try it again.The patient inquired if there were other patients who had a pyloroplasty and enterra and what was their outcome.The patient reported that their device was removed because it ¿kind of failed.¿ the patient was referred for intestinal transplant, the surgeon did an open lap on her, an exploratory of her intestines and found out her pyloric sphincter was severely stenosed, nothing could go through it, it was occluded.They had pyloroplasty to open it up and removed their device during the surgery.The patient noted that they still had gastroparesis and was on tpn, they were in a lot of pain and had been experiencing nausea.The patient¿s 2nd device kept shocking them and turning itself off, they would turn it back on and it would turn off, it was off for a while.It was also noted that they worked at healthcare facility and they avoided the mri department.No recent medical test or emi environmental exposure was reported.The patient was scheduled to see their healthcare provider on (b)(6) 2017 to see if they could try the enterra again and stated that their pyloric valve was open and thought he device failed (turned off and was shocking patient) because nothing could be pushed through something that was blocked.The patient stated that they thought that the device failing was all related to the pyloric valve being 100%occluded (blocked).It was also noted that the patient stated that the pyloric valve which moves the food through was like a heart valve needed to be replaced due to it being blocked.No further complications are anticipated.

Manufacturer Narrative

It was indicated that the patient's weight was between (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

No new information.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They reported that the implant used to shock them down their femoral artery.They said the stimulation was turned off and the system was removed.The device was discarded.They noted that the removal was supposed to be in february, but had been postposed due to other issues.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• MDR Report Key: 6512423
• MDR Text Key: 73396856
• Report Number: 3007566237-2017-01532
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/16/2021

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: 07/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: 07/17/2017; 07/17/2017; 09/09/2021
• Supplement Dates FDA Received: 07/19/2017; 10/03/2017; 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR