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 Complaint, Ill-Defined (2331); Bowel Perforation (2668); Test Result (2695)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.(b)(4).

Event Description

It was stated that the patient was in the hospital for a pain, issue with right diaphragm and vagus nerve.The pain had been but was no longer stabbing, just constant.The patient had a chest/gi scan, which indicated a perforated bowel.The patient was put on a high dose of antibiotics for a week.The patient had a ct scan with contrast, where he had to drink barium, which indicated an area of leakage/abscess/small hole around the implant, and was indicating internal bleeding.The patient stated the health care provider thought the device may be rubbing on the stomach.The patient also stated he has a pressure wound on his amputation (foot), for which there was a question on the blood work.The indication for use for this patient was gastric stimulation.No further information was reported.Further follow up is being conducted to obtain additional information.A follow-up report will be sent if additional information becomes available.

• 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: 5163297
• MDR Text Key: 28796512
• Report Number: 3004209178-2015-21038
• 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
• Report Date: 09/24/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• 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: Not provided
• Initial Date FDA Received: 10/20/2015
• Date Device Manufactured: 08/29/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 00049 YR