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

Model Number 3116

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 10/19/2017

Event Type  malfunction  

Event Description

This device stopped working.The patient was scheduled for surgery to remove and insert new device.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC, INC.; 7000 central ave. n.e.; minneapolis MN 55432
• MDR Report Key: 6986529
• MDR Text Key: 90530106
• Report Number: 6986529
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3116
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR