MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA THERAPY

Model Number 435135

Device Problems High impedance (1291); Material Twisted/Bent (2981)

Patient Problem Erosion (1750)

Event Date 01/10/2014

Event Type  Injury  

Event Description

High impedance - lead malfunction.On (b)(6), initial implant of device (device info not available).(b)(6): revision - device explant due to lead erosion.(b)(6): new device implanted.(b)(6): explant of device.Lead malfunction due to "twisting" of leads.Implanted device serial number not available.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: 7040990
• MDR Text Key: 92513244
• Report Number: MW5073403
• 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: 11/14/2017
• 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
• Device Model Number: 435135
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR
• Patient Weight: 65