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); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Nausea (1970); Internal Organ Perforation (1987); Vomiting (2144); Foreign Body In Patient (2687)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2020, product type: lead; product id: 4351-35, serial#: (b)(4), implanted: (b)(6)2019, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot#: (b)(4), ubd: 24-sep-2021, udi#: (b)(4); product id: 4351-35, serial/lot#: (b)(4), ubd: 24-sep-2021, 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 with an implantable neurostimulator (ins) for the treatment of gastric stimulation.It was reported that impedance readings were normal at 520 ohms but the patient was still having nausea and vomiting symptoms.An esophagogastroduodenoscopy (egd) was performed on (b)(6) 2020 which discovered that the leads had migrated into the mucosa of the stomach.This was the reason for explant of the leads and ins on (b)(6) 2020.The patient stated they had been rough housing with their kids and they possibly kicked the patient accidentally.The event was resolved.No further patient complications were reported as a result of this event.

Manufacturer Narrative

H3 the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.The returned leads were subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The leads were returned segmented; however electrical testing of the returned segment(s) determined that continuity was complete and there were no electrical shorts between the circuits.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.

Manufacturer Narrative

H6: a150208 removed.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.

• 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: 10233220
• MDR Text Key: 197612733
• Report Number: 3004209178-2020-11590
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10."
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR