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

Model Number 37800

Device Problem Battery Problem (2885)

Patient Problem Nausea (1970)

Event Date 01/03/2022

Event Type  malfunction  

Event Description

Hold vm 10.24the patient received their first device in 2018 and believed it was supposed to last 5+.On (b)(6) 2021, the patient had to have the ipg replaced at which time, the physician noticed the leads and battery were fried.Following her replacement surgery in (b)(6) 2021, the replacement device was working fine going into 2022 but 3 months later in (b)(6), the physician found the battery to be dead again and the patient began to feel ill symptoms since the device was not working properly.

• Brand Name: ENTERRA II IPG
• Type of Device: GASTRIC STIMULATOR
• Manufacturer (Section D): ENTERRA MEDICAL, INC; 5353 wayzata blvd, ste. 400, s; saint louis park 55416
• Manufacturer Contact: jane mammen ; 5353 wayzata blvd, ste. 400; saint louis park 55416 ; 6513342011
• MDR Report Key: 17997236
• MDR Text Key: 326412882
• Report Number: 3027386225-2023-00010
• 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: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/30/2023

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
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female