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

Model Number 3116

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Muscle Spasm(s) (1966); Thrombosis (2100); Burning Sensation (2146)

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) 2013, product type: lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.(b)(4).

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for gastric stimulation and gastrointestinal/pelvic floor.It was reported that the patient had spasms in the stomach and it felt like it was on fire.This occurred in (b)(6) 2015.The patient first said it was 6 months ago, but then clarified it was in (b)(6) 2015.The patient wondered if the implantable neurostimulator (ins) could cause the symptoms.The patient saw the healthcare professional (hcp) in (b)(6) and the hcp said one of the leads was not right.It was noted that the patient had a blood clot in her intestines in (b)(6) 2015.There was no trauma or fall that could be related to this issue.There was no recent medical test or electromagnetic interference (emi) exposure.Further follow-up is being conducted to determine the cause of the lead issue, what serial or lot number of the lead involved with the issue, if the cause of the blood clot and stomach spasms was determined, to determine what actions, interventions or troubleshooting was performed.Further follow-up is being conducted.If additional information is received, a follow-up report will be sent.

• 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 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: 5487912
• MDR Text Key: 40075078
• Report Number: 3004209178-2016-04168
• 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: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• Date Device Manufactured: 04/18/2012
• 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