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

Model Number	353101
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_lead, lot# unknown, 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; product id: neu_unknown_lead, 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 unknown indications for use.It was unknown when the trial started.It was reported that whenever they sit down, they can feel the leads pushing in, which cause slight discomfort.However, they do not feel it when standing.They also stated that the discomfort was tolerable.It was unknown whether the issue was resolved.
Event or Problem Description
Additional information was received from the health care professional (hcp).The hcp stated that the trial was initiated on (b)(6) 2025.The ens was used for the treatment of urge incontinence.When the hcp was asked to clarify what steps were taken to resolve the lead pushing in while sitting, the hcp stated that the patient was placed in the prone position.The lower back and upper buttock region was prepped and draped in the usual manner.They measured 9 cm from the coccyx and 2cm lateral to this and 2 cm superior.These were the approximate locations of the needle entry points.The patient was anesthetized both sides.A needle was then placed through the left foramen.With stimulation, the patient reported feeling the stimulation in the rectum of the ipsilateral side.The wire was placed through the needle and the needle was removed.Stimulation of the wire resulted in the same sensory and motor responses that were observed with the stimulation of the needle.The needle was then plac ed through the foreman on the right, and this resulted in rectal sensation when stimulated.The wire was placed through the needle, and needle was removed.Stimulation of the wire resu lted in the same sensory and motor response that were observed with stimulation of the needle.The wires were coiled at the skin level and then two small tegaderm dressings were applied.Additional dressings were then placed.There were no evidence of intraoperative complications.
Additional Manufacturer Narrative
Continuation of d10: product id neu_unknown_lead lot# unknown implanted: (b)(6) 2025: product type lead product id neu_unknown_lead lot# unknown serial# implanted: (b)(6) 2025: product type lead 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
H3: analysis of the ens (s/n: (b)(6)) revealed that the returned device passed all testing in the laboratory and no anomalies were identified.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
• 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: 21301329
• Report Number: 2182207-2025-00321
• Device Sequence Number: 12822984
• Product Code: EZW
• UDI-Device Identifier: 00763000879280
• UDI-Public: (01)00763000879280(11)240926(21)NLM739528N(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2025
• Supplement Date Received by Manufacturer: 02/10/2025; 08/29/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/24/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Female