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

Model Number 37800

Device Problems Entrapment of Device (1212); Material Erosion (1214)

Patient Problem Failure of Implant (1924)

Event Date 07/24/2019

Event Type  malfunction  

Event Description

Patient was having an enterra generator exchange.During surgery, the provider noticed that the leads had eroded into the stomach.An esophagogastroduodenoscopy was performed so the lead(s) could be cut endoscopically and removed.Generator exchange was not possible since the leads had to be cut and will require additional surgery as therapy was helpful to patient.Devices placed in a different facility.

• Brand Name: ENTERRA® II
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC, INC.; 7000 central ave., n.e.; minneapolis MN 55432
• MDR Report Key: 8905915
• MDR Text Key: 154728560
• Report Number: 8905915
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 37800
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2019
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1