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

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Vomiting (2144); Malaise (2359); Insufficient Information (4580)

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 patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation and gast rointestinal/ pelvic floor.It was reported that the patient said they were very sick when they got the device and was on a long list if ever getting better.Patient said after getting the device they were placed on top of the list of getting better.Patient said they were getting better till the device "broke".Patient said the device migrated from the left side of their ribs to their belly button.Patient said they knew the device "broke" because their symptoms returned.Patient said their digestive track is paralyzed and they don't have diabetes.Patient said they have cyclic vomiting.Patient said the hcp they were seeing moved and the other healthcare provider (hcp) they have seen don't work with the device or just want to remove it.  patient was not able to provide an event date because they were in a serious accident a few years ago and their memory was erased.Agent did not ask about the circumstances that led to the reported issue.The patient was redirected to their healthcare provider to further address the issue.

• 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
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13196553
• MDR Text Key: 289224846
• Report Number: 3004209178-2022-00331
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2022
• Date Device Manufactured: 09/08/2011
• 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 Sex: Female
• Patient Weight: 52 KG