MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION THERAPY ENTERRA THERAPY SYSTEM; GENERATOR

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Information (3190)

Event Date 05/09/2016

Event Type  Injury  

Event Description

Implanted device replaced due to reported "shocking".On (b)(6) 2015: implant enterra device; generator # - not available, (b)(4).On (b)(6) 2016: revision of implant due to reported "shocking" (implant information - not available).Dates of use: (b)(6) 2015 - (b)(6) 2016.Diagnosis or reason for use: gastroparesis.

• Brand Name: ENTERRA THERAPY SYSTEM
• Type of Device: GENERATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION THERAPY; 7000 central ave. ne; rce250; minneapolis MN 55432 3576
• MDR Report Key: 7066887
• MDR Text Key: 93327835
• Report Number: MW5073620
• 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
• 3 Devices were Involved in the Event: 1 2 3

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
• Other Device ID Number: NHT024740N
• 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
• 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: 22 YR
• Patient Weight: 81