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

Model Number 37800

Device Problems Energy Output Problem (1431); Overheating of Device (1437); Electromagnetic Compatibility Problem (2927); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Dehydration (1807); Unspecified Infection (1930); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 09/07/2017

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

A patient with an implantable neurostimulator (ins) indicated for gastric stimulation/gastrointestinal stimulation/pelvic floor, reported they began having stomach pain on (b)(6) 2017 that lasted for a few hours, so they went to the emergency room.They also began having symptoms like prior to implant.X-rays were done, which showed a bowel obstruction and a hernia.The patient said they had a mesh in their stomach, they got it removed due to it being stuck to the mesh, as well as addressed the hernia.The patient stated they were in the hospital and hadn't felt well/right, and if she eats, she is nauseous or vomits.No further complications were reported/anticipated.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.Patient codes (b)(4) and (b)(4) no longer apply.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the consumer on (b)(6) reported she had been in pain, so much pain she wanted to die, was nauseous and had been vomiting for 7 days straight now and was nauseous.The patient stated she was so sick that she couldn¿t do anything, she couldn¿t even drink ginger tea or take anti-nausea pill because she would throw them up.The patient stated she went to the hospital on (b)(6) because the implant started ¿burning¿ in her stomach.The patient stated she felt hot and cold and she know that there was an infection somewhere in her body, but didn¿t know where, the patient stated it was a feeling that she never had before getting the device.The patient noted she had been to the emergency room (er) twice about this, but the er didn¿t know what to do and the hospital had tried to contact the manufacture representative (rep) about the issue.The patient stated the hospital asked if the rep could come and see the patient on (b)(6), but the rep said he couldn¿t make it and ¿told¿ the hospital to send the patient home and that he would see her on (b)(6).The patient stated the hospital told her she was dehydrated and had sent her home twice and the patient was at home twice and the patient was at home at the time of the report and still vomiting.The patient stated if she went back to er she didn¿t now what they would do.The patient stated the rep attempted to call her on (b)(6) but she was too sick to answer at the time, but the patient called the rep and the rep told her he wouldn¿t available to meet the patient until (b)(6).The patient stated that was the 2nd time ¿in a year¿ that had happened to her where the er didn¿t know what to do regarding her implant.The patient stated the first time she had gone to the hcp for the non-device related reasons of having abdominal pain.The patient stated she went to the er because she thought the pain she was having was because of the im plant wasn¿t working, but it turned out the pain was from a hernia and bowel obstruction that was not related to the device, so she had to emergency surgery for that right after labor day in (b)(6) 2017.The patient stated after a few days of being in the hospital she started to vomit and had pain so they called a rep.The patient stated the hospital didn¿t know what to do regarding the patient¿s device when the patient thought something was going on with it and she had to get her gastrointestinal hcp involved that had nothing to do with the device and finally the rep was contacted and came out to check the device.The patient stated the rep gave her an hcp list, but those hcp didn¿t deal with the rep.It was noted the patient had an appointment with the rep and hcp on (b)(6).The patient noted they had a return of vomiting right after labor day in (b)(6) 2017 and a return of symptoms on (b)(6) 2018.There were no further complications that have been reported as a result of this event.

• 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 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6879419
• MDR Text Key: 86755410
• Report Number: 3004209178-2017-19707
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

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: 07/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 09/28/2018
• Date Device Manufactured: 02/11/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 46 YR