MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION THERAPY ENTERRA THERAPY

Model Number 37800

Device Problem Material Erosion (1214)

Patient Problem No Information (3190)

Event Date 06/09/2016

Event Type  Injury  

Event Description

Replacement of implanted device.On (b)(6) 2009: initial implant enterra device (b)(4).On (b)(6) 2016: device explant due to lead erosion.On (b)(6) 2016: implant enterra device.Device implants: generator: (b)(4), lead 1: (b)(4), lead 2: (b)(4).On (b)(6) 2017: device explant due to lead erosion.Dates of use: (b)(6) 2016.Diagnosis or reason for use: gastroparesis.

• Brand Name: ENTERRA THERAPY
• Type of Device: ENTERRA THERAPY
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION THERAPY; 7000 central ave. ne; rce250; minneapolis MN 55432 3576
• MDR Report Key: 7066881
• MDR Text Key: 93316289
• Report Number: MW5073617
• 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
• 4 Devices were Involved in the Event: 1 2 3 4

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: 37800
• 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: 41 YR
• Patient Weight: 77