MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 08/14/2018

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 healthcare professional (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor.It was reported the patient had a kidney transplant on (b)(6) 2018 and started getting increased nausea and vomiting symptoms after the operation.The rep noted they spoke the hcp on (b)(6) and he gave the rep his current settings should be.The rep noted his on time to 3 seconds and off to 2 seconds and increased his rate from 28 to 10.The rep noted the troubleshooting they increased programming settings.It was noted it was not known if the issue was resolved at the time of the report.The rep noted there was no surgical intervention and there was none planned.The patient was listed as alive with no injury at the time of the report.There were no further complications that have been reported as a result of this event.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 7822261
• MDR Text Key: 120128003
• Report Number: 3004209178-2018-19209
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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: company representative,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 08/28/2018

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: 02/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 08/28/2018
• Date Device Manufactured: 08/21/2014
• 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: 43 YR
• Patient Weight: 66