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

Model Number 3116

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Device Overstimulation of Tissue (1991); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Abdominal Distention (2601)

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.

Event Description

A healthcare professional (hcp) initially reported on (b)(6) 2012 that a consumer had a loss of some therapeutic effect since last appointment about 1.5 weeks ago when she was asymptomatic, with a partial return of bloating, nausea, vomiting symptoms.The hcp was wanting to adjust stimulation, and adjusted to 6 v per instructions and the consumer felt into her back so instructed to reduce to 4.5 v.It was noted that typical voltage for consumers was 2 v but the hcp said the consumer was a severe case.Additional information received from the consumer on 2016-nov-29 reported that the implantable neurostimulator (ins) area was as hard as a rock since about three years ago.She noted therapy problems up and down, with stomach bloating and sticks out since a couple of years after being implanted.Two weeks ago ((b)(6) 2016), her other side of the stomach started bloating up.The consumer asked her doctor to check the ins, who indicated there were only three (3) devices in the city.The doctor then called her and stated her device was not working.The consumer reported the whole thing was not working.She could go all day without eating and her stomach sticks out.She could just eat sugar free jello and yogurt for breakfast.The consumer noted that she did not drive, she had a nervous breakdown, and ect treatments, and her husband was disabled.The consumer reported a doctor was no longer available at the hospital.She noted she may be in the er tomorrow because she was inpain and looked like she was 9 months pregnant and swollen and alleged that this was because the ins was not working.Additional information received on 2016-nov-30 from the consumer report ed that therapy worked for about a year and ever since she had trouble.Her stomach was bloated and she was in pain, and thought the ins had depleted.

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: 6210437
• MDR Text Key: 63617212
• Report Number: 3004209178-2016-27327
• 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,Followup
• Report Date: 12/28/2016

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: 06/14/2013
• 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: 11/29/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 11/29/2016
• Supplement Dates FDA Received: 09/28/2017
• Date Device Manufactured: 12/20/2011
• 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: 49 YR