MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problems High impedance (1291); Insufficient Information (3190)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 4351-35.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient¿s impedance was over 800 and the lead in question was showing greater than 20,000.The hcp ended up removing the lead that they thought might be slightly outside of the stomach that might have been causing the problem.They replaced the lead and the impedance dropped into normal range.It was also reported that the patient hadn¿t done extremely well in alleviating their symptoms, but they had gained some weight since the implant.This issue happened several months prior to the report and was noted to be resolved at the time of the report.No further complications were reported or anticipated.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the cause of the issue was that the lead did not have sufficient tissue coverage at the surgical implant.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# unknown, product type lead.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 NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8014112
• MDR Text Key: 125299237
• Report Number: 3007566237-2018-03162
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

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
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 52