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

Model Number 37800

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395); Positioning Problem (3009)

Patient Problems Necrosis (1971); Pain (1994); Malaise (2359); Insufficient Information (4580)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351,serial#: unknown, product type: lead.Other relevant device(s) are: product id: 4351, serial/lot #: unknown.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 and gastrointestinal/pelvic floor.It was reported that the patient reported their device was implant probably in (b)(6) 2018, they had it for about 5 months, then it was removed.The patient said ever since implant, it kept popping out, it never stayed in.The patient said, the healthcare provider (hcp) had the patient wear compression around their stomach, but since the patient had gastroparesis stomach issues, the patient told the hcp that was not working so he went back in and did another surgery in (b)(6) 2019 to secure it with mesh but after that, the patient got severely sick.The patient said in (b)(6) 2019, they told their hcp they cannot take this pain so they did a ct scan and found the leads were entangled in their small intestine, the patient already had gangrene all over the small intestine so the patient lost their small intestines and is now having lots of problems because of this.No further complications were reported.

Manufacturer Narrative

Continuation of d10: product id 4351-35 lot# serial# (b)(6) implanted: explanted: product type lead product id 4351-35 lot# serial# (b)(6) implanted: explanted: product type lead 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.

Manufacturer Narrative

D6: implant date is approximate.Continuation of d10: product id 4351-35, serial# (b)(6), implanted: (b)(6) 2017, explanted: (b)(6) 2019.Product type lead product id 4351-35, serial# (b)(6), implanted: (b)(6) 2017, explanted: (b)(4) 2019.Product type lead 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.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.

Event Description

Additional information was received.It was reported that in (b)(6) of 2018 (never registered) patient received the enterra implant to treat gastroparesis however they only experienced problems with the implant from the beginning.Patient said that the neurostimulator was popping out of their stomach area so in (b)(6) 2019 (end of january) the surgeon performed revision of the neurostimulator and patient said they think that the surgeon pushed too hard and the leads became entangled with the small intestine.Patient said that on (b)(6) 2019 went to the er due to the continual pain since the surgery and they did perform a scan and that is when it was discovered that the leads were entangled with the small intestine.Patient said that they was placed into icu and had immediate surgery in which the neurostimulator was removed however because the leads were entangled, about 1./ of their small intestine was removed.Patient said that as a result of this emergency surgery, they have not had a good quality of life and has found a healthcare team in washington, dc that will perform a small intestine transplant and is calling manufacturer as a resource for funding options for this surgery.The patient's relevant medical history included patient said that prior to implant that patient lost her large intestine.

Manufacturer Narrative

This information was merged into this file, it had been previously submitted in rr # 2182207-2021-01793 on (b)(6) 2021 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
• MDR Report Key: 12488188
• MDR Text Key: 271907513
• Report Number: 3004209178-2021-14025
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Life Threatening
• Patient Age: 37 YR