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

Model Number 37800

Device Problems Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Internal Organ Perforation (1987); Complaint, Ill-Defined (2331); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 11/24/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 4351-35, explanted: (b)(6) 2017, product type: lead.Product id: 4351-35, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2017 mpxr 481519 (hcp, rep): a manufacturing representative (rep) reported on behalf of a healthcare provider (hcp) that a patient experienced a lead erosion.At least one lead eroded into the patient's stomach, possibly both.The leads were removed and replaced.It was noted that the issue was resolved at the time of the report.No further complications were reported/anticipated.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id (b)(6) lot# serial# (b)(6) implanted: (b)(4) 2014 explanted: (b)(4) 2017 product type lead product id (b)(6) lot# serial# (b)(6) implanted: (b)(4)2014 explanted: (b)(4) 2017 product type lead if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Other applicable components are: product id 4351-35 (b)(4) implanted:(b)(6) explanted: (b)(6)product type lead product id 4351-35 (b)(4) implanted: (b)(6) explanted: (b)(6) product type lead (b)(4).Device codes: (b)(4), patient codes: (b)(4) (b)(4) (b)(4) pertain to product id 4351-35 (b)(4) product type lead and product id 4351-35 (b)(4) product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the cause of the lead erosion was unknown and it was unknown if the lead erosion was related to the device or therapy.The patient had no known exposure to magnets, the device remained on the appropriate settings, and impedance was discovered incidentally by gastroenterologist who performed a scope for worsening symptoms.No further complications were reported/anticipated.

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.

Manufacturer Narrative

Continuation of d10: product id 4351-35 lot# serial# (b)(6), implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type lead product id 4351-35, serial# (b)(6), implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type lead this information was submitted incorrectly with regulatory report 3004209178-2021-01375, 3004209178-2021-01375-001, and 3004209178-2 021-01375-002.The error was noted today (b)(6) 2021.The related event will also be updated/corrected.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 provider.It was reported the suture from the leads were left in the stomach.A picture of the prolene suture from the leads in the stomach was included.They weren't sure if this was from the previous leads that were left in the stomach, or the current leads.It was noted this had been seen on endoscopy.It was unknown if the issue was resolved.They reported there was no harm or symptoms reported with relation to the lead remaining in the patient's body.No additional surgery or procedure will be done to remove the component in the future.The cause of the original lead being left in the stomach was unknown.It was noted that the remaining suture was most likely from the old device as the current system was functioning normally.The issue remained unresolved, but no further action was going to be taken.

• 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 MN 00777 1200
• MDR Report Key: 7103487
• MDR Text Key: 94349576
• Report Number: 3007566237-2017-05115
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; "SEE H10...."; "SEE H10...."
• Patient Outcome(s): Life Threatening
• Patient Age: 56 YR
• Patient Weight: 87