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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Erosion (1750); Internal Organ Perforation (1987); Vomiting (2144); Electric Shock (2554)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 4351-35 lot# nht028112n serial# implanted: (b)(6) 2016 explanted: product type lead product id 4351-35 lot# nht028110n serial# implanted: (b)(6) 2016 explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(6), ubd: 15-feb-2018, udi#: (b)(4) ; product id: 4351-35, serial/lot #:(b)(6), ubd: 15-feb-2018, udi#: (b)(4) 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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor therapy and gastric stimulation.It was reported that their stimulator was turned off this week because it was discovered that the "electrodes" had "eroded"/eroded through their stomach.The patient stated their managing health care provider (hcp) told the patient that they would need a replacement and that the nurse at the office would look into getting the replacement started however the patient hadn't heard anything from the hcp office yet.The patient stated they needed to know a timeline for when the replacement would occur because at the time of the call, they weren't able to keep anything down.When patient services asked for when the issue had started, the patient stated they had started getting "zapping sensations" back in (b)(6) 2022 and that nothing had been done about the issue until this week when the therapy was turned off.The patient stated that their current hcp didn't implant or perform procedures with the enterra therapy and that an hcp who was 3 hours away implanted the device initially and then a doctor had been the hcp that replaced their original ins when the battery had normally depleted.Patient services reviewed with the patient to continue to attempt to contact their hcp office and to get to an urgent care facility if needed but also reached out to the field to alert them of the situation.The patient was going to continue trying to contact their hcp in the meantime.Patient services sent an email to the field.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that the patient was seen by their dr on (b)(6) for a potential device adjustment.Patient stated that her symptoms had returned, and that their health care professional (hcp) had previously told her that her leads had eroded into the lumen of her stomach.However, hcp came in and confirmed that this was simply a miscommunication.That he had previously told her that lead erosion was a potential reason for symptom return, not that this patient's leads had eroded.They interrogation of the patient's stimulator with an 8840 programmer revealed impedance was within normal range.Hcp recommended a one step up in the energy algorithm, which i performed on the 8840 under his supervision.Patient was seen a month later in his clinic again, and stated that her symptoms had improved, but were still present.Patient has a follow up appointment with dr.Hughes' clinic in august, but the leads and device are still active and in service.

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.

• 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: 16904075
• MDR Text Key: 314926365
• Report Number: 3004209178-2023-06224
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2023
• Date Device Manufactured: 10/08/2019
• 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
• Treatment: "SEE H10."
• Patient Outcome(s): Life Threatening
• Patient Age: 35 YR
• Patient Sex: Female