MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD. VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 353101

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Data Problem (3196)

Patient Problems Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Rash (2033); Fluid Discharge (2686); Insufficient Information (4580)

Event Date 10/11/2023

Event Type  Injury  

Event Description

Information was received from a trial patient who was using an external neurostimulator (ens) for bowel issues.It was reported that their trial began on wednesday (b)(6) 2023 and that they were supposed to have it for a week but they might also do it for two weeks because of their unique situation: the patient stated they didn't have a colon so their small intestine was attached to their anus which made them susceptible to getting dehydrated/they were always dehydrated and they were always horribly sensitive to the anesthesia.The patient stated the pain meds from the anesthesia at their trial procedure shut their bowels down.So they knew it wasn't working as well as it could have for their symptoms for the first two days because they had been really constipated.The patient stated for their condition they couldn't have firm stools, they needed to have watery/diarrhea type stools.The patient stated they were groggy initially in the hospital so they didn't remember what they were told for tracking their symptoms and that the setting must have been accidently changed while they had the therapy settings pulled up by getting "bumped" or something while it was on their hospital bed so the therapy hadn't been working/they had a lot of trouble yesterday.The patient stated when they talked to support link they were able to go back to the stimulation setting they were supposed to be on.The patient stated they had been told they could increase the stimulation if they needed to so the patient increased the stimulation and that they felt that the therapy was working for their symptoms now at least by 50%.The patient had initially called to ask about their representative's (rep's) name was because they had questions about tracking their symptoms.Patient services reviewed the role of the rep with the patient and redirected the patient to follow up with their managing health care provider (hcp).The patient stated that not all of the symptoms on the paper tracker they had were applicable to them and their condition and that support link had told them based on the symptoms they were reporting that the therapy appeared to be helping but the patient didn't think they were tracking all of their necessary symptoms so they didn't think the symptom data was accurately reflected and they didn't know what they were doing so they weren't really able to tell if the therapy was working or not.The patient wanted to know what was considered an accident and asked if leakage counted.They also stated they didn't know that they were supposed to rank their stool and consider the fecal test range and bristol.Patient services reviewed the role of patient services and redirected the patient to follow up with their hcp about their symptom tracking concerns.The patient stated they had tried to call the health care provider (hcp)'s office however they were really busy and they hadn't been able to get through.The patient was going to continue monitoring their symptoms and continue to follow up with support link and their hcp.Please note this patient was difficult to follow at times and patient services did their best to document the r eported information.Additional information was received from the patient.It was reported that the patient had an incision site infection.They reported that the pt was scheduled for stage 2 implant today but prior to the case the pt was c/o severe itching under the tegaderm.The dr removed the tegaderm and the pt had a severe rash and redness at the lead insertion site as well as the ins pocket with a little bit of fluid discharge.The dr opted to explant the lead and send it and a wound culture to check for infection.Once the pt is healed she will be reimplanted later.

Manufacturer Narrative

Concomitant medical products:product id 978b128 lot# va2qshq serial# implanted: (b)(6) 2023 explanted: (b)(6) 2023 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(6), ubd: 24-apr-2024, udi#: (b)(6) 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: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD.; bayan lepas fiz, phase ii; bayan lepas,pin 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD.; bayan lepas fiz, phase ii; bayan lepas,pin 11900 ; MY 11900
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18048267
• MDR Text Key: 327079762
• Report Number: 3004593495-2023-00005
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000344573
• UDI-Public: 00763000344573
• Combination Product (y/n): N
• PMA/PMN Number: P080025
• 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
• Report Date: 11/01/2023

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 Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/01/2023
• Date Device Manufactured: 10/19/2022
• 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