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

Model Number 37800

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Diarrhea (1811); Eructate (1839); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Constipation (3274)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported that they felt a rapid sensation in their stomach "that goes kind of funny, like when scared." they weren't comfortable with the sensation.They thought it might their heart, but their breathing was fine and they felt fine.It was located in their stomach area since (b)(6) 2017.They also mentioned having bad/worsening diarrhea since implant that slowed down after (b)(6) 2017, and now they were constipated.The constipation occurred between (b)(6) 2017.Previously they were not full like they were all the time and were belching more.Now it was like a natural thing as some as they ate or while eating.Before they would belch a little.This change occurred (b)(6) 2017.There were no further complications reported as a result of this event.The indication for use was gastric stimulation.

• 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: 6738032
• MDR Text Key: 80882041
• Report Number: 3004209178-2017-15452
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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: 07/24/2017

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: 09/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 07/24/2017
• Date Device Manufactured: 03/15/2017
• 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: 58 YR