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

Model Number 3116

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Diarrhea (1811); Pyrosis/Heartburn (1883); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2008, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2008, product type: lead.(b)(4).

Event Description

The consumer reported a loss of therapy.Her symptoms returned on (b)(6) 2015.They were as before being implanted.She could not take it anymore and went to the hospital on (b)(6) 2015 and stayed for 2 days.It was determined on (b)(6) 2015 that the implantable neurostimulator (ins) battery was dead.Physician listings were requested for replacement.The patient experienced severe heartburn, diarrhea, vomiting, pancreas, and "everything." this was noted to be sudden.It was then stated that it was determined that the battery was depleted on (b)(6) 2015.Relevant medical history included gastric stimulation.Follow-up was performed to determine what actions were taken to address the event and if it was resolved.This event will be updated if additional information is received.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5178739
• MDR Text Key: 29289173
• Report Number: 3004209178-2015-21501
• 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
• Report Date: 10/02/2015

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: 07/28/2014
• 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: 10/02/2015
• Initial Date FDA Received: 10/26/2015
• Date Device Manufactured: 01/30/2013
• 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 Outcome(s): Hospitalization
• Patient Age: 00046 YR