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

Model Number 37800

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Nausea (1970); Vomiting (2144); Electric Shock (2554)

Event Date 04/24/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient experienced a return of nausea and vomiting with intermittent shocking.Both leads were replaced.Contributing factors were unknown, the patient did not report a ny falls or trauma to the device, impedance checks were done in office and the healthcare provider reported them to be normal  (less than 800 ohms, exact number was unknown).The doctor took x-rays of the stomach and egd, both were inconclusive.They proceeded to take to surgery to replace the leads in order to resolve the shocking and restore efficacy.The issue was resolved.It was reported that the leads were replaced, the ins was still in use.  [relevant medical history: nausea and vomiting due to gastroparesis].

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial#: (b)(4), explanted: (b)(6) 2022, product type: lead; product id: 435135, serial#: (b)(4), explanted: (b)(6) 2022, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 30-mar-2013, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 30-mar-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id: 435135, serial#: (b)(6), explanted: 2022 (b)(6), 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.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that after patients leads were replaced they went home the next day with improved nausea/ vomiting and no more intermittent shocking.

Manufacturer Narrative

Continuation of d10: product id 435135, serial# (b)(6), explanted: (b)(6) 2022, product type: lead, product id 435135, serial# (b)(6), explanted: (b)(6) 2022, 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

Continuation of d10: product id 435135 lot# serial# (b)(4) explanted: (b)(6)2022 product type lead product id 435135 lot# serial# (b)(6) explanted: (b)(6)2022 product type lead h3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The lead was 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.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 MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14337017
• MDR Text Key: 291212860
• Report Number: 2182207-2022-00760
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 05/11/2022; 07/18/2022; 08/03/2022
• Supplement Dates FDA Received: 06/01/2022; 07/21/2022; 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 66 KG