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

Model Number 353101

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 04/13/2024

Event Type  malfunction  

Event Description

Information was received from a trial patient who was using an external neurostimulator (ens) for urge incontinence and urgency frequency.It was noted that the patients trial started on (b)(6) 2024.It was reported that the patient hit max stimulation, followed steps in troubleshooting tab.Additional information was received on (b)(6) 2024, patient stated she has some blood around her incision site.Patient is receiving a communication error on her programmer.Patient experienced bleeding, device malfunction, worsening symptoms than before: bladder, leads dislodged.

Manufacturer Narrative

Continuation of d10: product id neu_unknown_lead lot# unknown serial# implanted: (b)(6) 2024 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 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: 19212971
• MDR Text Key: 341843969
• Report Number: 2182207-2024-02438
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• 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
• Date Manufacturer Received: 04/13/2024
• 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 Age: 78 YR
• Patient Sex: Female