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

Model Number	353101
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional 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.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 or Problem Description
Information was received from a trial patient who was using an external neurostimulator (ens) for non-obstructive urinary retention.Their trial start date was (b)(6) 2023.It was reported that the patient was experiencing discomfort/soreness/pinching.It is unknown if the issue was resolved. the patient reported they were still sore from the procedure yesterday ((b)(6) 2023) but they were calling to inquire about the stimulation sensation.The patient wanted to know if the stimulation should stay in the same place or not because the stimulation felt like it was "rotating" for them between their penis, groin and lower buttocks.The patient further explained that during the procedure when they were laying on their stomach, they felt the stimulation in their penis area and groin area but when they were standing it felt more towards the buttocks and when they were sitting it felt like it was lower.Patient services reviewed stimulation considerations and therapy expectations with the patient.The patient confirmed the stimulation was comfortable for them and stated the therapy was definitely helping their symptoms of chronic urinary retention by more than 50% reduction.The patient stated they usually had a little amount come out when they would pee but since the trial they were definitely seeing a better stream and that was a big improvement for them.Patient services redirected the patient to continue following up with their health care provider (hcp) with symptom related questions.Patient was going to continue monitoring their symptoms.

• Brand Name: VERIFY ENHANCED
• Common Device Name: 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: 17894121
• Report Number: 2182207-2023-02048
• Device Sequence Number: 2453574
• Product Code: EZW
• UDI-Device Identifier: 00763000344573
• UDI-Public: 00763000344573
• Combination Product (Y/N): N
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2023

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
• Operator of Device: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 10/09/2023
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male