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

Model Number	353101
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 306001, lot# unknown, implanted: (b)(6) 2024, product type screening device.Product id 306001, lot# unknown, implanted: (b)(6) 2024, product type screening device.Section d information references the main component of the system.Other relevant device(s) are: product id: 306001, serial/lot #: unknown.Product id: 306001, serial/lot #: unknown.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.
Event or Problem Description
Information was received from a trial patient who was using an external neurostimulator (ens) for urgency frequency.Their trial started on (b)(6) 2024.Additional information was received from the patient on (b)(6) 2024 stating that the leads have dislodged.Additional information was received from the patient on 2024-sep-11 stating that their device was removed early as a result of the leads becoming dislodged and unable to reconnect.Additional information was received from the healthcare provider (hcp) stating that the patient had their post op appointment on (b)(6) 2024 and went home and has not been seen since then.The patient does not want to proceed with stage 2 trial.
Additional Manufacturer Narrative
Continuation of d10: product id 306001, lot# unknown, implanted: (b)(6) 2024, product type screening device, product id 306001, lot# unknown, implanted: (b)(6) 2024, product type screening device.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.
Event or Problem Description
Additional information was received from the healthcare provider (hcp) stating that the patient had their post op appointment on (b)(6) 2024 and went home and has not been seen since then.The patient does not want to proceed with stage 2 trial.
Additional Manufacturer Narrative
Continuation of d10: product id: 306001, lot# unknown, implanted: (b)(6) 2024, product type screening device, product id 306001, lot# unknown, implanted: (b)(6) 2024, product type screening device.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.
Additional Manufacturer Narrative
Continuation of d10: product id 306001 lot# 60565992, implanted: (b)(6) 2024, product type screening device product id 306001 lot# 60570948, implanted: (b)(6) 2024, explanted: product type screening device 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20375645
• Report Number: 2182207-2024-04114
• Device Sequence Number: 17080199
• Product Code: EZW
• UDI-Device Identifier: 00763000879280
• UDI-Public: 00763000879280
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/04/2024; 10/11/2024; 11/20/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/03/2024; 11/03/2024; 11/29/2024
• Date Device Manufactured: 07/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11....".
• Patient Age: 72 YR
• Patient Sex: Male