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 Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Burning Sensation (2146); Hernia (2240); Complaint, Ill-Defined (2331); Abdominal Distention (2601)

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.

Event Description

The healthcare provider (hcp) reported via the manufacturer representative (rep) that the patient came to the hcp's office the week prior to the report and wanted their device removed.They didn't really give a good reason, just that it wasn't working.It was indicated that the patient had nausea, vomiting, bloating, severe burning, and a feeling that it was being ripped out of their body.The patient saw another hcp yesterday, and that hcp did not want to remove the device.They felt there was too much danger of full thickness damage of the stomach wall.The patient was scheduled to see the hcp on (b)(6) 2017 to assess removal.Additional information received stated that the patient saw the hcp on (b)(6) 2017.They were going to schedule to have the device removed sometime in (b)(6) 2017.The issue was not resolved.There were no further complications reported as a result of this event.The indication for use was gastrointestinal/pelvic floor and gastric stimulation.

Manufacturer Narrative

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

Event Description

Additional information received reported the patient's device was removed on the day of the report.The leads were adhered to the stomach wall and that may have caused some of the pain.The patient also felt that they were allergic to the device.They said they were allergic to all metal except gold.No further complications were reported/anticipated.

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: 6667694
• MDR Text Key: 78421853
• Report Number: 3004209178-2017-13724
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Date Device Manufactured: 11/15/2013
• 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): Required Intervention