MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problem Malposition of Device (2616)

Patient Problems Chest Pain (1776); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The consumer reported that the patient was not having a good time with it yet and it hurt a lot.She had a temporary ng tube put in.The patient was just implanted two days ago and was in longer than they thought she would be.The patient was very tiny because of the gastroparesis (she was (b)(6)) but she was not diabetic.The implanting health care professional (hcp) said he put it lower and he could have put it higher by the ribs but ended up implanting lower.The patient could not sit up straight on the toilet because it bumped into her pelvic bone.The patient had told her hcp about their concerns.The patient was on 10 different drugs and was lactose intolerant.The patient had not gotten sick (nausea) since having the implant.They were still recovering from the implant surgery and notified the hcp of concerns with the implantable neurostimulator (ins) discomfort.It was further reported by the hcp on (b)(6) 2015 that the patient had incisional pain and chest pain after placement.Lower voltage and pain medication resolved the issue.The indication-for-use (ifu) was gastric stimulation and gastrointestinal/pelvic floor.If additional information is received, a follow-up report will be sent.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 5357631
• MDR Text Key: 35549457
• Report Number: 3004209178-2016-00332
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2015

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: 01/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/11/2016
• Date Device Manufactured: 07/16/2015
• 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; Required Intervention
• Patient Age: 00012 YR