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 Unspecified Infection (1930); Nausea (1970); Sepsis (2067); Therapeutic Response, Decreased (2271)

Event Date 01/01/2017

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 consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient had been having issues like sepsis and other infections, which started in 2017.They also stated that the therapy helped, but sometimes they would want to throw up, but couldn¿t.This was a loss of therapy and had been happening since 2018.No device issues or further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the patient had a consultation scheduled with a new physician on (b)(6) 2019 to discuss removal of the device.The patient clarified that by ¿other infections¿ they meant that they had sepsis and other blood infections.The patient was not sure if the sepsis was related to the device or therapy and mentioned that it could be, but also could be related to their other issues.It was noted that the patient had one episode of a sepsis infection prior to the device being implanted in (b)(6) 2016 and two other episodes of sepsis afterwards.The patient wanted to get testing done to resolve the loss of therapy and inability to vomit but with the restriction of not being able to get mris with the device implanted, the patient thought that this limited the testing that they could do.No other actions or interventions were taken to resolve the issues and they were not currently resolved.The patient was planning to remove the device, but the explant surgery had not been scheduled yet.No further complications were reported or anticipated.

• 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: 8373677
• MDR Text Key: 137253221
• Report Number: 3004209178-2019-04081
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2019
• Date Device Manufactured: 04/04/2016
• 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): Life Threatening; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 36