MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Break (1069); Unintended Collision (1429)

Patient Problems Abdominal Pain (1685); Hypoglycemia (1912); Nausea (1970); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Abdominal Cramps (2543); Weight Changes (2607); Constipation (3274)

Event Date 08/01/2014

Event Type  malfunction  

Manufacturer Narrative

Main component of the system and other applicable components are: product id 435135, serial # (b)(4), implanted: (b)(6) 2006, product type lead; product id 435135, serial # (b)(4), implanted: (b)(6) 2006, product type lead.

Event Description

A consumer whose indication for use was gastric stimulation reported that she experienced a loss of therapy.She was nauseated all the time and could not really eat.She had stomach problems such as pain, cramping and stomach hurt.Her bowel movements were irregular, not digesting things properly and she gained weight.These symptoms started in (b)(6) 2015.She thought that it was time to have the implantable neurostimulator (ins) replaced if it was not already dead.She was getting hypoglycemic really easily.The consumer further reported that the patient needed to have their device checked and it was past time for their implant battery to be replaced.The patient had been having problems for several months now, but it had gotten worse in the past few weeks in (b)(6) 2016.The patient thought their gastrointestinal tract was slowing down.The patient¿s problems were trouble eating, nausea, very constipated, indigestion, and stomach discomfort.The health care provider (hcp) the patient had an appointment with in february, but the hcp was no longer practicing.The patient thought their electrodes may be damaged due to several falls in 2014, 2015, and 2016 after they had their stroke a year and a half ago in (b)(6) 2014.The patient had balance problems due to the stroke.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5657864
• MDR Text Key: 45283084
• Report Number: 3004209178-2016-09577
• 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,Followup
• Report Date: 05/16/2016

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 Expiration Date: 03/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: 04/21/2016
• Supplement Dates FDA Received: 09/22/2017
• Date Device Manufactured: 09/29/2010
• 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 Age: 57 YR