MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994)

Event Date 05/06/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient saw the healthcare provider (hcp) on (b)(6) 2022 and had nausea and lower abdominal pain.The healthcare provider (hcp) referred to another hcp to get a battery replacement.The patient has pocket pain from the battery.A revision has been scheduled.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14601638
• MDR Text Key: 293346771
• Report Number: 2182207-2022-00978
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000286798
• UDI-Public: 00763000286798
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/06/2022
• Date Device Manufactured: 06/26/2020
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 75 KG