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

Model Number 37800

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Erosion (1750); Internal Organ Perforation (1987); Pain (1994); Paresis (1998); Vomiting (2144); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial#: unknown, implanted: (b)(6) 2019.Other relevant device(s) are: product id: 4351-35, serial/lot #: unknown, ubd: 03-jul-2020.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) and a manufacturer representative who was implanted with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/ pelvic floor.It was reported that the patient's device "quit working" and they have been "real sick".The pt reported they couldn't figure out what was going on, so they "were upping it".They reported experiencing "real bad burning, shooting and stinging pain" where the stimulator is located.The pt stated this all started "about a year ago" and they had been in and out of the er due to pain and throwing up.The pt reported they had a gastric empty scan that showed that they were only emptying at "like 6%".The pt stated due to this they were sent to a doctor in (b)(6) and had an "endoflip" done on (b)(6) 2022 where it was discovered that the pt had a lead that had come loose from their stimulator and "went into my stomach instead of on the outside of my stomach".The pt's reason for call was to inquire about what to do regarding lead that had come loose from stimulator.The patient was redirected to their healthcare provider to further address the issue.The patient's relevant medical history included pt stated they have gastroparesis.On (b)(6) 2022, a manufacturing rep rereported that during the endoscopy in (b)(6) it was discovered that a lead had eroded into the stomach.A lead revision was now scheduled for (b)(6) 2022.The issue was not resolved at the time of the report.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that the leads had migrated into the stomach and the doctor removed the leads and replaced them with new ones.

Manufacturer Narrative

Continuation of d10: product id 4351-35.Unknown implanted: (b)(6) 2019, 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

Concomitant medical products: product id 4351-35 lot# serial# (b)(6) implanted: (b)(6) 2019 explanted: (b)(6) 2022 product type lead product id 4351-35 lot# serial# (b)(6) implanted: (b)(6) 2019 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.

Event Description

Additional information was received from a healthcare professional (hcp).The hcp reported that both leads had migrated into the stomach.The devices were discarded.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13371544
• MDR Text Key: 289260011
• Report Number: 3004209178-2022-01304
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2022
• Date Device Manufactured: 01/04/2019
• 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): Life Threatening
• Patient Sex: Female
• Patient Weight: 93 KG