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)

Patient Problems Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015: product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 04-aug-2017, udi#:(b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 04-aug-2017, udi#: (b)(4).(b)(4).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).It was reported in (b)(6) 2018, the lines were wrapped around the patient¿s intestines and with surgery from a perforation, were found.The patient stated on (b)(6) they had an appendectomy and the healthcare professional (hcp) found one of the leads had grown into their intestines and a resectioning had to be done.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information from a consumer regarding a patient with implantable neurostimulator (ins) reported she had two surgeries within the past 6 months because of her device.The patient stated that the device lines were wrapped around her intestines and she was not sure if she had an infection because of it.The patient was transferred to patient services.It was reported on (b)(6) 2018 the lines for the device were wrapped around her intestines cause a blockage.The patient stated on (b)(6) 2018 one of the lines grew into her intestine and they had to do a restricting and would have to replace or remove the device, so it didn't keep happening.The patient reported she was going to the hospital (b)(6) 2018 multiple times for a lot of a pain and they didn't know what the problem was at the time.The patient noted with the device her stomach would not function.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

H6: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.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: 7980112
• MDR Text Key: 124490435
• Report Number: 3004209178-2018-23376
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 28 YR