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

Model Number 37800

Device Problem Material Perforation (2205)

Patient Problem Abdominal Pain (1685)

Event Date 03/25/2023

Event Type  Death  

Event Description

The patient had an uneventful gastric stimulator placement.She had stomach to anterior abdominal wall adhesions that were taken down at the beginning of the case.The leads were placed into the designated area of the stomach.An egd was performed, and the patient had some retained food in the stomach, which is not uncommon.The scope was used to gently move the food aside so the area opposing the leads could be visualized.The remainder of the case was standard, including sewing the leads into place and placing the battery.The following morning that patient complained of abdominal pain and was instructed to go to the emergency room.She went to (b)(6).There she was reported to have a perforation.She became septic later that night and coded.She was taken to the operating room and found to have a perforation so the device was removed due to contamination.She remained in critical condition and died the following day.There is no association of her death with the stimulator device.

• 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: 18004556
• MDR Text Key: 326508600
• Report Number: 3027386225-2023-00014
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37800
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• 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): Death
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 49 KG