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

Model Number 353101

Device Problems Energy Output Problem (1431); Malposition of Device (2616)

Patient Problems Pain (1994); Transient Ischemic Attack (2109); Discomfort (2330); Ambulation Difficulties (2544); Cognitive Changes (2551); Embolism/Embolus (4438)

Event Date 04/09/2023

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 reported that they turned ens off yesterday, but are still feeling like "the monitor is going" and is "working".Caller wanted to know if that was okay to turn ens off.Reviewed patient options.Caller stated they think they had a mild stroke.Caller said they can't get mri done with ens wires, but healthcare professional (hcp) can't see them until wednesday to take ens out.Caller was frustrated that ens was causing a delay in getting mri done and having to stay in hospital longer.During call, had caller connect with ens and confirm that it was turned off.On (b)(6) 2023 caller called back.Caller reports that they did not have a ct scan, reviewed risks with ct and trial.The caller reports that the hcp came to the hospital this morning and pulled the leads, so the patient is able to have an mri later today.On (b)(6) 2023, patient reported that there was suspicion that the device was causal or contributory to the mild stroke.They stated that the ens was put in on thursday and by sunday, patient was not making any sense.They were in and out of it and could not make contact and was incoherent.They also weren¿t able to walk to the car without assistance.They went to the hospital and was admitted.The ens was still on so they turned it off.The following day, monday, patient was still feeling the vibrations even after ens was turned off but said the cause was just residual.They made sure it was turned off, and issue has since resolved.Patient said they needed an mri, so the nurse came to the hospital and took out their leads.Patient said it hurt and had pressure during lead take out.They also reported that the left side lead was never used because it was not placed in correct location.By tuesday, they were diagnosed with a mild stroke with a clot in their left side brain.The patient did report that the therapy worked fantastic.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_lead lot# unknown serial# implanted: 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: unknown, udi#: unknown 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.

• 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: 16890635
• MDR Text Key: 314805368
• Report Number: 2182207-2023-00826
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• 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: 05/08/2023

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
• Device Operator: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/08/2023
• 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): Required Intervention
• Patient Age: 71 YR