MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Twiddlers Syndrome (2114)

Event Date 12/01/2016

Event Type  malfunction  

Event Description

The consumer reported feeling pain and their implant moving.There were two different times where the patient felt their implant was moving; the first time, the patient had to ¿move it to push it flat¿ and ¿flipped up onto the side [having to] push it flat to turn.¿ it was noted that the events occurred a couple nights ago.The second time the patient leaned over and felt sharp pain like it was on its side.As a result, the patient ¿pushed on it¿ which made the device flat again and the pain to go away.Additional information from the healthcare provider stated no diagnostics were performed other than a physical exam.The cause was ¿possibly¿ the patient pushing and playing with stimulator.Actions and interventions included an abdominal binder.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6271472
• MDR Text Key: 65575344
• Report Number: 3007566237-2017-00233
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2017

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: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 01/23/2017
• 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