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

Model Number 37800

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/15/2023

Event Type  malfunction  

Event Description

The patient in question had an enterra gastric stimulator implanted in 2022, the entire system was removed and a new device was implanted on 15 december and there is a concern that she may now be having a delayed allergic reaction to the pouch.This particular patient has a hx of doxycycline allergy.Listed contraindication is for hx of allergy to tetracyclines which is in the same class.Patient had a follow up appointment on (b)(6) 2024 to discuss options, patient wanted to keep the device and manage "infection".Received email from medtronic patient registrations referencing a complaint.Patient has medtronic tyrx pouch that was used with our enterra device.Patient has a hx of doxycycline allergy.Listed contraindication is for hx of allergy to tetracyclines which is in the same class.The patient in question had an enterra gastric stimulator implanted in 2022, the entire system was removed and a new device was implanted on (b)(6) and there is a concern that she may now be having a delayed allergic reaction to the pouch.

• 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: 18790340
• MDR Text Key: 337623251
• Report Number: 3027386225-2024-00015
• Device Sequence Number: 1
• Product Code: LNQ
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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 This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Female