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

Model Number 3116

Device Problems Loss of Data (2903); Device Operates Differently Than Expected (2913)

Patient Problems Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Date 01/01/2015

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 consumer reported that the patient had repeated issues of symptom return due to loss or programming or issues with programming since 2015.The patient was vomiting and the symptom return was sudden.The patient went to see their health care provider (hcp) and the programming was not what was programmed and it was lower or barely on.They put it back on 7.0v and the symptoms resolved, but then it happened again.The ins was continually losing programming.The patient never saw their hcp and always saw their technician.The patient would consult with a new hcp to resolve the issue.The indication for use for this patient was gastric stimulation.

Event Description

Additional information received from the consumer reported that the patient notified their managing health care provider (hcp) about the return of symptoms and programming issues.The patient made an appointment to see their hcp, but only saw a medical assistant who was no longer working in the office as of (b)(6) 2016.The circumstance that led to the programming issues was that the machine setting apparently shifted for no known reason or exposure, so the patient reset it and watched it periodically.The step taken to resolve the return of symptoms and programming issues was that they set the unit a bit higher to try and address the issues.The patient didn't get out much, so they were unsure what could make the settings shift.The patient planned to go in within the next couple of months to see if the settings had held since reset in (b)(6) 2016.

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: 5611003
• MDR Text Key: 43778715
• Report Number: 3004209178-2016-08319
• 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,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2016
• Date Device Manufactured: 12/05/2011
• 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: 56 YR