MAUDE Adverse Event Report: MEDTRONIC ENTERRA THERAPY; ENTERRA

Device Problems No Device Output (1435); Failure to Read Input Signal (1581); Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 07/18/2017

Event Type  Injury  

Event Description

Device explant / revision due to dysfunctional implant.(b)(6) 2011: initial implant generator (b)(4), lead (b)(4).(b)(6) 2011: revision due to "flipped" generator.(b)(6) 2016: revision due to unresponsive device.(b)(6) 2017: revision of device, relocated, reprogrammed.(b)(6) 2017: generator exchange due to dysfunctional stimulator generator: (b)(4).Diagnosis or reason for use: gastroparesis.

• Brand Name: ENTERRA THERAPY
• Type of Device: ENTERRA
• Manufacturer (Section D): MEDTRONIC; 7000 central ave ne; rce250; minneapolis MN 55432 3576
• MDR Report Key: 7066835
• MDR Text Key: 93351272
• Report Number: MW5073614
• Device Sequence Number: 2
• 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: 11/28/2017
• 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: No Information
• 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: 53 YR
• Patient Weight: 69