MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Therapeutic Response, Decreased (2271); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 3116, serial#: (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 09-dec-2013, udi#: (b)(4) ; product id: 3116, serial/lot #: (b)(4), ubd: 28-nov-2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for gastric stimulation.It was reported that the patient was doing well until about a year and a half prior to the report when they presented to the hcp with a lot of nausea and pain.They discovered that the patient¿s leads had eroded into their stomach.At the time of the report, the patient was in the hospital for hematemesis, nausea, and pain.A ct scan at this time was negative.The hcp noted they couldn¿t control the pain.The rep was walking the hcp through turning off the device when the programming screen had the impedance out of range.When they looked closer, the impedance was as follows: 2<(>&<)>c = 257, 3<(>&<)>c 240, and 2<(>&<)>3 = 357.When they went back to the programming screen and ran an impedance check again, it stated it was out of range.The device was then turned off.The issue was not resolved at the time of the report and the hcp was undecided on their next steps.No further complications were reported or anticipated.

Event Description

Additional information received from a manufacturer representative (rep).It was reported that the rep wasn¿t sure what was causing the impedance issues.

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: (b)(6) 2012, product type lead, product id 3116, serial# (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep).It was reported that the cause of the leads eroding into the stomach was not determined.

Manufacturer Narrative

Continuation of d11: product id 435135 lot# serial# (b)(6), implanted: (b)(6) 2012, explanted: product type lead, product id 3116, serial# (b)(6), implanted: (b)(6) 2012, product type implantable neurostimulator.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.

Event Description

Additional information was received from the healthcare professional (hcp) via the manufacturer representative (rep).It was reported that the device was removed due to erosion.No patient complications were reported as a result of this event.

Manufacturer Narrative

Continuation of d11: product id 435135, serial# (b)(6), implanted: (b)(6) 2012, product type: lead; product id 3116, serial# (b)(6), implanted: (b)(6) 2012, product type: implantable neurostimulator.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

Correction: after further review, it was determined that the product information in section d had not been correctly submitted.The information in section d is now correct and should be considered correct in any future supplemental reports.Previously g9/current g8: 3007566237-2020-00325 correct fda site id (of ins): 3004209178 correct mfg.Site id (of ins): p1026 continuation of d10: product id: 435135, lot# nht016657n, implanted: (b)(6) 2012, explanted: (b)(6) 2020, product type: lead.Product id: 435135, lot# nht016656n, implanted: (b)(6) 2012, explanted: (b)(6) 2020, product type: lead.H6: due to imdrf harmonization, some previously submitted device, patient, 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.

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative (rep).It was reported that the patient had a removal of their total implant on (b)(6) 2020.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• MDR Report Key: 9953434
• MDR Text Key: 192427471
• Report Number: 3007566237-2020-00325
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10..."; "SEE H10...."
• Patient Outcome(s): Life Threatening; Required Intervention