MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA THERAPY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/05/2015

Event Type  Injury  

Event Description

Device revision due to malfunction.(b)(6) 2013: initial implant nhv109339h, nht020191n, nht020190n.On (b)(6) 2013: revision / removal of leads.On (b)(6) 2014: implant stimulator , leads nhv110131h, nht021170n, nht021575n.On (b)(6) 2015: revision of device generator due to malfunction (device info not available.) 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: 7066837
• MDR Text Key: 93365350
• Report Number: MW5073615
• 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
• Report Date: 11/13/2017
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

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: 11/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 27 YR
• Patient Weight: 63