MAUDE Adverse Event Report: MEDTRONIC, INC. ENTERRA; INTESTINAL STIMULATOR

Model Number 4351-35

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2023

Event Type  malfunction  

Event Description

During a laparoscopic gastric pacemaker insertion and electro lead insertion, when the surgeon put the needle into the trocar, the needle came off and landed on the floor.A new device was obtained and the case continued without issue.The needle did not fall in or harm the patient.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 17821067
• MDR Text Key: 324301005
• Report Number: 17821067
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4351-35
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2023
• Date Report to Manufacturer: 09/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA