MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA THERAPY

Model Number 435135

Device Problems Material Erosion (1214); High impedance (1291); Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 01/10/2014

Event Type  Injury  

Event Description

High impedance - lead malfunction.On (b)(6) 2013: initial implant of device (device information not available).On (b)(6) 2013: revision - device explant due to lead erosion.On (b)(6) 2013: new device implant.On (b)(6) 2014: explant of device: lead malfunction due to "twisting" of leads.Implanted device serial number - not available.Dates of use: (b)(6) 2013 - (b)(6) 2014.Diagnosis or reason for use: gastroparesis.

• Brand Name: ENTERRA THERAPY
• Type of Device: ENTERRA THERAPY
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave. ne; rce250; minneapolis MN 55432 3576
• MDR Report Key: 7066914
• MDR Text Key: 93353107
• Report Number: MW5073623
• 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

• Date FDA Received: 11/29/2017
• 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
• 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: 44 YR