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

Model Number 3116

Device Problem Unintended Collision (1429)

Patient Problems Diarrhea (1811); Pyrosis/Heartburn (1883); Vomiting (2144); Complaint, Ill-Defined (2331)

Event Date 12/01/2015

Event Type  malfunction  

Event Description

A consumer reported needing the stimulator to be adjusted because she fell in (b)(6) last year and broke three ribs.She fell on the same side the stimulator was located and her health had been deteriorating.When she got the device, she was eating properly and it was helping her digest the food she ate.Now, she was having a lot of heartburn, throwing up, and was either throwing up or had really bad diarrhea.It was uncontrollable and she was not eating as much.The consumer noted that she guessed about 2 or 3 months after the fall she began having these symptoms.She needed doctor listings because her doctor does not take her insurance.She was implanted for her inflammation sickness.Indication for use included gastric stimulation and gastrointestinal/pelvic floor.

Manufacturer Narrative

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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6110329
• MDR Text Key: 60288108
• Report Number: 3004209178-2016-24281
• 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,Followup
• Report Date: 11/17/2016

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: 06/28/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: 10/26/2016
• Supplement Dates FDA Received: 09/27/2017
• Date Device Manufactured: 01/04/2013
• 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: 68 YR