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

Model Number 3116

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problem Paresis (1998)

Event Date 05/23/2016

Event Type  malfunction  

Event Description

The health care provider (hcp) via a manufacturer representative reported that the patient's battery turned off and they were not doing well in regards to their gastroparesis symptoms.Their previous settings were lower than they were before.This happened about 2 to 3 months prior to the patient's visit on (b)(6) 2016.The hcp wanted to know what could cause a battery to inadvertently turn off.The patient had not had previous surgery.The hcp turned the patient back on.It was unknown if any environmental, external, or patient factors may have led to the event.The troubleshooting performed and the actions taken to resolve the issue were unknown.The issue was resolved and the patient was alive with no injury.No surgical intervention occurred and no surgical intervention was planned.The indication for use for this patient was 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: 5952370
• MDR Text Key: 54778233
• Report Number: 3004209178-2016-18964
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2016

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: 10/14/2014
• 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: 08/23/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: 08/23/2016
• Supplement Dates FDA Received: 09/25/2017
• Date Device Manufactured: 04/17/2013
• 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: 57 YR