MAUDE Adverse Event Report: ENTERRA MEDICAL, INC. ENTERRA II IPG; GASTRIC STIMULATOR

Model Number 37800

Device Problem Unintended Movement (3026)

Patient Problem Implant Pain (4561)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

Patient called the patient liaison line and states she had enterra therapy implanted in 2008 and the provider has retired.She said her device was turned off a couple years ago.She was reaching out to find a new provider closer to her.She states yesterday she vomited and felt a pull and has had extreme pain over the site of her device.The patient states she was on the way to the emergency room when she called and has her id card.We reviewed the closest providers in montana and the patient took down the contact information.

• Brand Name: ENTERRA II IPG
• Type of Device: GASTRIC STIMULATOR
• Manufacturer (Section D): ENTERRA MEDICAL, INC.; 5353 wayzata blvd, ste. 400; saint louis park MN 55416
• Manufacturer Contact: jane mammen ; 5353 wayzata blvd, ste. 400; saint louis park, MN 55416 ; 6513342011
• MDR Report Key: 18311787
• MDR Text Key: 330354189
• Report Number: 3027386225-2023-00018
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000449704
• UDI-Public: 00763000449704
• 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: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female