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 Paresis (1998); Vomiting (2144); No Code Available (3191)

Event Date 08/01/2019

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 regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient had been ¿fighting several infections¿.The patient had a procedure on august 26th because they had an abscess in their head that had an infection and had to have it drained.The abscess got worse over the ¿period of a week¿ and got ¿bigger and bigger¿ in the patient¿s head.It was noted that the patient had an infection before the abscess, but they did not know it.Cultures were taken and confirmed the infection.The patient was discharged from the hospital last thursday and was re-admitted on friday because they were vomiting blood and had been trying to eat for the past couple days but was ¿not able to keep anything down¿ and had not been able to eat due to the vomiting.The patient thought it may be a ¿gastro problem¿.It was noted that the vomiting started on friday, september 6th, following the infections, and the infections started in august, ¿maybe two weeks prior¿.The patient was in the hospital for the infections ¿for about two weeks¿ and the day after they were discharged from the hospital, they woke up with the vomiting and was re-admitted; the patient was currently in the hospital.The infection in the patient¿s head was drained on the day of the report and cultures were taken again, but results were not yet available.It was noted that the patient also had an infection in their ¿picc line, central line¿ and that the patient knew the infection was ¿messing¿ with their ¿gastroparesis¿.No further complications were reported/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: 9105535
• MDR Text Key: 162728272
• Report Number: 3004209178-2019-18191
• 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
• Report Date: 09/23/2019

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: 01/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/23/2019
• 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
• Patient Age: 33 YR