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

Model Number 37800

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

Patient Problems Diarrhea (1811); Pain (1994); Therapeutic Effects, Unexpected (2099); Constipation (3274)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor issues.It was reported that the patient had been complaining of pain and a lack of efficacy with their device; it was causing diarrhea then it was causing constipation.The patient wanted the device removed and had tried to turn the device off for a period of time to see if their symptoms were better or worse.It was unknown what environmental/external/patient factors may have led or contributed to the issue.The issue was not resolved at the time of the report; however, the patient was scheduled to have their implant removed on (b)(6) 2018.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp).It was reported that the hcp didn¿t think this was due to an issue with the device.

• 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 PUERTO RICO OPERATIONS CO.; 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: 7830216
• MDR Text Key: 118714160
• Report Number: 3004209178-2018-19477
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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
• Report Date: 09/19/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 09/19/2018
• Date Device Manufactured: 06/18/2015
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 61