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

Model Number 37800

Device Problem Battery Problem (2885)

Patient Problem External Prosthetic Device Pain (4560)

Event Date 12/15/2023

Event Type  Injury  

Event Description

Pt is experiencing what she describes as pain near her battery pocket.Originally she described it as thinking it was happening every 5 seconds.So, she saw a provider with a programmer and the device was checked (impedance was well in range on all electrodes).They then turned battery off.Pt has still been experiencing the same pain.Working on getting her in to see her surgeon as next steps.

• 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: 18438267
• MDR Text Key: 331829595
• Report Number: 3027386225-2024-00001
• 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: 01/03/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• 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: 32 YR
• Patient Sex: Female