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

Model Number 37800

Device Problems Battery Problem (2885); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Discomfort (2330); Swelling/ Edema (4577); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 435135 serial# (b)(4) implanted: (b)(6) 2012 product type lead product id 435135 serial# (b)(4) implanted: (b)(6)2012 other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 17-aug-2014, udi#: (b)(4) ; product id: 435135, serial/lot #: (b)(4), ubd: 17-aug-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation it was r eported that the reason for the call was that the patient reported their implant was dead, and they had a question about replacing just the implant versus replacing the whole system.The patient reported it seemed like they had been doing a lot more physical therapy this year, and they felt like there was something being pulled, and a soreness under the device as well as swelling and tenderness that went up to the belly button.The patient reported they had talked to a few health care providers (hcps), so they could not remember if one of them said this or if the patient thought this, but the patient believed their current hcp wanted to replace their entire system because they felt "like the wires are corrosive at this point," with the pain they were getting from the device.The patient reported they noticed this pain for about a year and a half, but then stated it could have been some time in 2019 or 2020 when the pain began.The patient was going to continue to follow up with their physician to discuss the further steps that needed to be taken for replacement.They were redirected to follow up with their healthcare provider.

Event Description

Additional information was received from the patient.They reported that when doing their physical therapy at the gym, device location is painful, patient stated the device battery dead was not due to normal depletion as it never really worked well and is still sore underneath pocket and running up to the chest and that they are waiting for the replacement date.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14018067
• MDR Text Key: 289432066
• Report Number: 3004209178-2022-04292
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2022
• Date Device Manufactured: 07/06/2016
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 75 KG