MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Device Problem Energy Output Problem (1431)

Patient Problems Abdominal Pain (1685); Nausea (1970); Shaking/Tremors (2515)

Event Date 12/09/2022

Event Type  Injury  

Event Description

Problems with enterra device, severe nausea, abdominal pain, and new onset tremor.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 16052477
• MDR Text Key: 306282122
• Report Number: MW5114024
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White