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

Model Number 3116

Device Problems High impedance (1291); Energy Output Problem (1431); Battery Problem (2885); Electromagnetic Compatibility Problem (2927)

Patient Problems Hemorrhage/Bleeding (1888); Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Vomiting (2144)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated; month and year are valid.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 multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that the caller stated that the patient has had a return of symptoms and the nurse practitioner (np) noticed, upon interrogation today, a few things were out of the ordinary.Caller had np on the line with them.Np stated that typically patient's gastroparesis has been well controller and ins was last interrogated (b)(6) 2021 and showed therapy impedance of 608 ohms with battery reading of low.However, since (b)(6), patient has had a return of nausea and vomiting symptoms and pain at ins site.Np stated that, at one point, patient presented to the er with a tear causing them to vomit blood.Np stated that patient also has cardiac complications along with uncontrolled diabetes so it was first thought that patient's symptoms were possibly due to other medical events going on.Np stated that upon interrogation today, ins was on and therapy impedance was 608 ohm (which was similar to previous interrogations) and amplitude was at 7.2v despite that, at last visit, it had been set to 7.5v and it hasn't been changed since then.Caller noted that current today was 5.0 ma and last interrogation it was 8.0 ma.Np mentioned that when they ran impedances, they saw the typical enterra pairs: c-2 430 ohms, c-3 415 oh ms and 2-3 608 ohms but other values were listed as well (c-0, 0-1, c-1, etc.) that showed, as expected for enterra, over 4k ohms.When np checked the ins today for the battery reading, it initially showed low, but then showed ok with capacity of greater than 120.Np also noted that during interrogation, they received message about interference with verbiage to the effect of "device is receiving signal from another device" - np confirmed that patient doesn't have any other implantable devices and had patient remove their cell phone from their pocket near the ins.Np also noted when they palpated patient's ins, it was painful to touch.Agent asked if np had noticed any odd message (i.E.Power on reset) upon interrogation but they didn't notice anything.Troubleshooting asked if patient had undergone any medical procedures using cautery or defibrillation but np didn't know.At the end of the appointment today, np left patient at current settings with ins on.The caller was not with the patient.Agent reviewed that, with information provided, there may be an intermittent impedance issue somewhere or potential fluid short at ins header block.Troubleshooting reviewed that since it is unknown what exactly is occurring with the ins and the fact that it showed low about a year ago, they may want to consider ins replacement at this time.Agent also sent email to np so they can share pictures of 8840 they took during the session.

• 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: 15786442
• MDR Text Key: 303542005
• Report Number: 3004209178-2022-14936
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2022
• Date Device Manufactured: 10/06/2014
• 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; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female