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

Model Number 37800

Device Problem Failure to Deliver Energy (1211)

Patient Problems Fever (1858); Unspecified Infection (1930); Vomiting (2144); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Ambulation Difficulties (2544)

Event Date 10/19/2017

Event Type  Injury  

Event Description

A patient reported that they had been terribly sick since they got their device implanted.They stated that after the device was implanted they went home from the hospital running a fever and they had to go back a week later because "it had all busted open".The patient said the hospital sent them home without any antibiotics and with a fever over 100 degrees for more than 2 hours.They were never given any antibiotics at all.The patient further stated they got an infection in the pocket and it busted open, right below where they cut in their belly button.The patient reported they went back to their healthcare provider's (hcp) office twice and they checked the incision, but they never put the clinician programmer over the device and kept getting sicker and sicker.The weekend prior to the report the patient said they were ungodly sick, and they started throwing up friday until tuesday.They said they were going to commit themselves to a mental institution because they thought they were losing their mind.They met with their gastric hcp and they found that the device was never even turned on after it was implanted.They wanted to know if there were any kind of complications that they needed to watch for due to having the implant inside of their body while it was off.The implant was in their stomach as a foreign object for three weeks while it was off.They were sore on the day of the report and could hardly move.This was their second implant and they stated the 1st implant surgery was nothing like it.The patient did say that once the therapy was on, their gastroparesis symptoms got better.Another thing the patient mentioned was that they were trying to get off of all the gastroparesis medications they were on and it that it was all trial and error.They thought they still had one medication that made them kind of nauseated, but once that passes, they had not been nauseated at all and it had been such a blessing.The nausea was caused by the medication, not the device, the patient confirmed.No further complications were reported/anticipated.Additional information from the healthcare provider hcp reported that the ins was turned on in the operating room and stayed on.The gastroenterologist doesn't program the stimulators, they did (implanting surgeon).They stated they did not know why the patient said that.The infection the patient had was in the umbilical trocar site, not in the pocket.They saw the patient post operation on day 6 which was the first time they called and opened the umbilical trocar site and cultured.They started the patient on antibiotics and it healed fine.The patient had no fever in the hospital, the hcp reviewed vital signs.They also had pyloroplasty after replacing the battery and closing the pocket.That introduced bacteria into the trocar.It was noted that the infection resolved.The remainder of the additional information was not clear at the time of the report and follow-up is being conducted to gather more information.

• 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: 7097510
• MDR Text Key: 94163171
• Report Number: 3004209178-2017-25593
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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
• Type of Report: Initial
• Report Date: 12/07/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/07/2017
• Date Device Manufactured: 08/29/2017
• 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: 52 YR
• Patient Weight: 55