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

Model Number 37800

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 11/07/2023

Event Type  malfunction  

Event Description

Product returned to medtronic for analysis.Information taken from medtronic product return data spreadsheet.Products were returned to medtronic and analyzed - ipg passed functional testing; no analysis results for leads were recorded.

• 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: 19217238
• MDR Text Key: 341438746
• Report Number: 3027386225-2024-00033
• 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: 04/03/2024

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: 04/30/2024
• 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