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

Model Number 37800

Device Problems Unstable (1667); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, product type: lead.Product id: 353101, serial#: unknown, product type: external neurostimulator.Other relevant device(s) are: product id: 353101, serial/lot #: unknown.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.It was reported that the patient stated their stimulator was popping out and it was painful.Patient stated that if they were getting up from sitting or bending over, the ins will flip.Patient stated it was not up and down it was sideways, the top of the unit was pushing on the incision, and it made a bulge.Patient added that they ran it by their surgeon and they didn't give much feedback.He said he can remove it.She doesn't want to remove because it helps.Patient wanted to have a revision or have it anchored, the surgeon said it could not be anchored.Patient indicated that this had been going on since day one.The patient was redirected to their healthcare provider to further address the issue.Additional information was received indicating that the patient had an issue with their trial.Patient stated when home, they heaved, then gaged causing the lead to come loose from the stomach and it coiled in their throat.Patient said that she pulled the whole thing out herself.Patient stated they hyperventilated it hurt so bad.And blood was everywhere.No further complications were reported at this time.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation and gast rointestinal/ pelvic floor.The patient called on (b)(6) 2021 and mentioned they were having issues with the battery, it was popping out and it was very painful.They were transferred to patient services.Additional information stated that the incision or pocket area was flat.If the patient got up from sitting or bent over, it would flip.They top of the unit was pushing on the incision and making it bulge.If they pushed on it, the stimulator would go flat, it was painful.They ran it by the surgeon who said they could remove it.They didn't want to remove it because it helped.They wanted a revision or to have it anchored.It was noted the surgeon said it couldn't be anchored.They said this had been occurring since day 1.They were redirected to their healthcare provider to further address the issue.[relevant medical history: pyloroplasty the month prior to implant, still recuperating and in a lot of pain when they got the implant, doctor only have 1 week of pain medication so they had been spreading it out to try to make it last longer].

Manufacturer Narrative

Report type corrected updates made to coding trial information omitted from this report; see manufacture's report 2182207-2021-01088 for report of trial information 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 00777
• MDR Report Key: 11980184
• MDR Text Key: 267159812
• Report Number: 3004209178-2021-09210
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000286798
• UDI-Public: 00763000286798
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR