MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA THERAPY

Device Problem High impedance (1291)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Implant replaced due to high impedance.On (b)(6) 2014: initial implant of device generator (b)(4), leads: (b)(4).On (b)(6) 2014: revision of device due to malfunction.Impedance noted above 1000.Device info not available.Lead (b)(4), generator: (b)(4).Dates of use: (b)(6) 2014.Diagnosis or reason for use: gastroparesis.

• Brand Name: ENTERRA THERAPY
• Type of Device: ENTERRA
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central avenue ne; rce250; minneapolis MN 55432 3576
• MDR Report Key: 7040980
• MDR Text Key: 92526694
• Report Number: MW5073399
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2017
• 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 Outcome(s): Hospitalization
• Patient Age: 23 YR
• Patient Weight: 60