MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; LEGACY ENTERRA

Model Number 3116

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2017

Event Type  malfunction  

Event Description

Device explanted because of malfunction and new device implanted.

• Brand Name: MEDTRONIC
• Type of Device: LEGACY ENTERRA
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 6785023
• MDR Text Key: 82566712
• Report Number: MW5071473
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 72