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

Model Number 37800

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Patient called patient liaison and states she has been having some problems with her stimulator.She states it is "over stimulating through chest wall and is painful." per patient she is feeling on and off stimulation in abdomen and chest wall spasms.Patient states she had enterra therapy replacement surgery with dr.Johnson, the crm record shows the surgery was (b)(6) 2023.She states she has felt the stimulation feelings since the surgery but states the stimulation feeling and spasms have gotten worse since 7/7/23 when she had a ct scan.

• 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: 17997491
• MDR Text Key: 326415496
• Report Number: 3027386225-2023-00012
• 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: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Female