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

Model Number 37800

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Nausea (1970)

Event Date 06/29/2023

Event Type  malfunction  

Event Description

Patient had "loose screw" in device, had revision (b)(6) 2023, now having refractory symptoms.In the past, had disconnected leads and had the leads replaced.Persistent nausea.Patient was also feeling impulses in the past due to disconnected leads, though is not currently experiencing this.Recent "loose screw" caused patient to undergo an additional surgery for revision.Device was first was placed in 2020.The leads came out and she was feeling the electrical impulses in 2022 so leads were replaced.She states she had to have another revision (b)(6) 2023 due to "loose screws" (physician took device out, cleaned it and fixed screw, and replaced).Since then, she "has not recovered well".She states that the device has been checked and is working ok.She continues to have the device settings increased, but continues to have severe nausea.The doctors have told her to give it more time.She does not have another follow up scheduled.The most recent adjustment was 1 week ago.Prior to her issues, she had complete relief of her nausea/vomiting, was living a "new life".

• 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
• MDR Report Key: 17997013
• MDR Text Key: 326410294
• Report Number: 3027386225-2023-00008
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2023

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 Model Number: 37800
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female