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

Model Number 37800

Device Problem Impedance Problem (2950)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/06/2024

Event Type  malfunction  

Event Description

Patient dob (b)(6) had her device replaced because the impedance was out of range.Dr.Implanted the device she is replacing on (b)(6) 2022.On (b)(6) 2024 device was interrogated with and was found to have an impedance out of range >800.On (b)(6) 2024 patient underwent surgery to identify issue with system.Dr.Tried tightening the set screws and the impedance normalized.Dr.Switched out the device because she didn't want the same issue to happen again.The replacement new devices serial number is (b)(6).The removed devices serial number is (b)(6).The set screw is suspected to have loosened over time.The removed device is being sent in for analysis to medtronic.

• 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: 18922608
• MDR Text Key: 337885347
• Report Number: 3027386225-2024-00024
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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
• 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): Other
• Patient Age: 88 YR
• Patient Sex: Female