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

Model Number 3116

Device Problems Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927)

Patient Problems Eructate (1839); Vomiting (2144); Insufficient Information (4580)

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Event date is approximate.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 gastrointestinal/ pelvic floor.It was reported that some of their symptoms have returned and are needing to find a doctor in their area that can help with getting a replacement.Pt states they have tried looking at the listings on the website but the only one that is close doesn't know what the enterra therapy is or what the pt is talking about.Pt states they can feel food, even when they eat the lightest food.Pt states then the next day they have the burps.Pt states they had an unrelated surgery a week ago and ate food 16 hours prior to the surgery.Pt states after the surgery they started puking everything up which is when they first noticed this 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: 12647388
• MDR Text Key: 276873835
• Report Number: 3004209178-2021-15472
• 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: 10/18/2021

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: 03/14/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 10/18/2021
• Date Device Manufactured: 09/22/2011
• 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 Age: 37 YR