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

Model Number 3116

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Nausea (1970); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 05/31/2018

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) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient felt an unusual twitching where their device was, noting it was like a smoke detector when the battery wore down; it was a twitching/hiccupping at the site.They wanted to know if this could have been an indication that the battery was wearing down or a lead was disconnected.The patient also reported that they were unable to eat again since this had been happening as they had a painful stomach and fullness.Additional information received on 2018-09-10 stated that the patient saw the hcp on (b)(6) 2018.Nothing led to the twitching/hiccupping at the device site, but the patient thought the battery was dying.They increased the speed of digesting, but it actually made it worse.At the time of the report, the patient had more twitching and could actually see the unit pull/contract and pull the leads.It was quite uncomfortable, but their nausea/fullness wasn¿t quite so bad.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that nothing changed with circumstances leading to the pulling/ contracting; the patient was doing some workout on the treadmill and walking outside.The patient thought the battery was dying because there was a change in the device, they started feeling full and nauseous again, and then the zapping/pulling from the pacemaker started.Now, 10 months later, it was very uncomfortable/painful on a daily basis and the patient goes to bed with a sore stomach area from the contractions/pulling from the leads.It was noted that the speed of digestion was increased and it had gotten worse with the zapping and pulling.No further complications were reported/anticipated.

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.

Event Description

Additional information was received from a consumer.It was reported that the patient¿s doctor would not replace the device until the battery was totally dead, and that it was very uncomfortable to live with that way.It was noted to be helping the patient¿s digestion very little at this point and if they had a small meal, they do not feel like eating the rest of the day.It was reported to have worked great for 5 ½ years, but now the patient was constantly having stomach pains.No further complications were reported/anticipated.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7895418
• MDR Text Key: 122104271
• Report Number: 3004209178-2018-21167
• 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
• Report Date: 01/24/2019

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: 05/28/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 10/05/2018; 01/22/2019
• Supplement Dates FDA Received: 10/31/2018; 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 91