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

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Memory Loss/Impairment (1958); Seizures (2063); Vomiting (2144); Malaise (2359)

Event Date 01/01/2016

Event Type  Injury  

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 they were feeling sick, vomiting, didn't know their own name, and has had seizures.The patient was not sure if the feeling sick was due to the gastritis or to their pump.The patient was feeling ill since (b)(6) 2016 off and on.The indications for use for this patient were 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: 5758461
• MDR Text Key: 48433823
• Report Number: 3004209178-2016-13146
• 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: 06/29/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2013
• 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: 06/07/2016
• Initial Date FDA Received: 06/29/2016
• Supplement Dates Manufacturer Received: 06/07/2016
• Supplement Dates FDA Received: 09/23/2017
• Date Device Manufactured: 02/08/2012
• 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): Other
• Patient Age: 52 YR