MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problems Failure to Deliver Energy (1211); Low Battery (2584); Positioning Problem (3009)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that the patient was looking for new hcp (healthcare provider) because the implantable neurostimulator (ins) depleted (b)(6) 2013.The patient had stomach cancer and needed her stomach removed and was going to have feeding tube placed.In (b)(6) 2013 her symptoms became gradually worse over a 10 day period and then after that all of a sudden and she said that she felt some tightening and fluttering in the area and then it stopped.When the stimulator was working, it would stick out whenever she ate.However, that no longer happens.The patient didn't have the device checked at that time because she didn't have insurance.The patient was experiencing a loss of therapeutic effect.The patient's symptoms were now worse and she could only eat once every 3 days, otherwise she gets sick.The patient was in the hospital last week because she ate two meals within 48 hrs.It was noted that the implant was performed day before (b)(6) in 2008.The patient had an appointment at a clinic on tuesday, (b)(6) 2014.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4322862
• MDR Text Key: 5241195
• Report Number: 3007566237-2014-03590
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization