MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 353101

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Fatigue (1849); Flatus (1865); Pain (1994); Discomfort (2330); Malaise (2359); Sleep Dysfunction (2517); Constipation (3274); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

Event Type  malfunction  

Event Description

Information was received from a trial patient who was using an external neurostimulator (ens) for urgency frequency and urge incontinence.It was noted that the patients trial started on (b)(6) 2023.It was reported that patient was concerned they may have moved the wires as they were "moving" the ens device around.Confirmed during call they were still feeling the stimulation while talking.The patient experienced pain, discomfort, constipation, diarrhea, malaise and sleep disturbance.Additional information was received on (b)(6) 2023, patient stated the first 24 hours was not a good day.They stated that they were in a lot of pain and kept telling the person they were talking to this.They were tired and only slept a couple of hours day 1.Patient stated that they were near constipation and then they got gas and the diarrhea started the other day.Patient stated they were unable to get off the toilet due to this.Patient stated they thought they pulled one of their wires out, but had increased their stimulation and was feeling it, so t hey knew it was not pulled out.Patient stated today their pain is getting better.Additional information was received on (b)(6) 2023, patient stated that they had experienced diarrhea last night.Additional information was received on (b)(6) 2023, patient reported swelling.Additional information was received on (b)(6) 2023 , the patient increased their stimulation on their own, but it became uncomfortable and they had to decrease it.Additional information was received on (b)(6) 2023, the patient stated they had back pain from the device along with preexisting back pain.Support link advised the patient please contact their clinician with questions regarding medical advice or if they had questions about their health.

Manufacturer Narrative

Continuation of d10: product id neu_unknown_lead lot# unknown serial# implanted: explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: 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): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17698671
• MDR Text Key: 322835042
• Report Number: 2182207-2023-01790
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• 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: 09/07/2023

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: 08/15/2023
• Initial Date FDA Received: 09/07/2023
• 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 Age: 75 YR
• Patient Sex: Female