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

Model Number 3116

Device Problems Energy Output Problem (1431); Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Nausea (1970); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) and from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that, starting on (b)(6) 2018, the patient reported to the hospital with increased nausea and abdominal pain.The next day, the patient reported that they thought they needed an adjustment to the stimulator because they were having stomach related symptoms and wasn't getting relief.These issues were noted to be sudden.No further complications were reported or anticipated.

Manufacturer Narrative

Initial reporter last name and phone number corrected.Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.Device, method, result, and conclusion codes updated.If information is provided in the future, a supplemental report will be issued.

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; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7625034
• MDR Text Key: 111887095
• Report Number: 3004209178-2018-13973
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 07/14/2012
• 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: 06/19/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 07/10/2018; 08/08/2018
• Supplement Dates FDA Received: 07/10/2018; 10/04/2018
• Date Device Manufactured: 01/16/2011
• 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: 48 YR