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

Model Number 3116

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hernia (2240)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient had their surgeon test their device every six months after they were implanted to have it tested and, every year, their device was still working.After a few years, their device failed.It was noted that it hadn't worked in a few years, but their healthcare professional (hcp) didn't want to replace or remove the device.The patient also reported they had had multiple hernias develop around the device.It was noted they already ¿naturally had an incisional hernia¿ and they didn't have any hernias prior to the device.No further complications were reported or anticipated.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8536251
• MDR Text Key: 142645531
• Report Number: 3004209178-2019-07948
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2007
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2019
• Date Device Manufactured: 09/12/2005
• 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