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

Model Number 353101

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Urinary Retention (2119)

Event Date 03/07/2024

Event Type  Injury  

Event Description

Information was received from a trial patient who was using an external neurostimulator (ens) for unknown indications for use.It was noted that the patients trial started on (b)(6) 2024.It was reported that  it should be working but it is not.Patient said they have not noticed any improvement to their symptoms, it makes them very tired, it has made them sleep in incredible amounts and they don't usually do that, they can't urinate, it is all the direct result of having metastatic prostate cancer 22 years ago.Pt said they have been speaking with support link but support link never asks them to change their setting, pt said they have until the 19th and wish to make a therapy adjustment to see if it will help.Pt said they called dr miller who was surprised it wasn't working.Worked with patient to synch with their settings and patient confirmed they had other program options.Reviewed some brief interstim evaluation information and offered to email the reps in the area to see if a rep would call them back.Offered and sent email to the local medtronic representatives.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19092822
• MDR Text Key: 339983272
• Report Number: 2182207-2024-02281
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/11/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/11/2024
• 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): Other