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

Model Number	353101
Medical Device Problem Codes	Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: neu_unknown_lead, lot#: unknown, implanted: (b)(6) 2023, 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.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a trial patient who was using an external neurostimulator (ens) for urge incontinence and urgency frequency.It was noted the patient's trial started on (b)(6) 2023.It was reported that they had a suspicion that something changed with the stimulator and when they tried to adjust stimulation to see if they felt changes the patient (pt) reported getting an error message.The pt initially reported on the call getting unable to communicate with device message (communication lost, ensure ens is in range and batteries are in place).The pt continued getting this message despite pressing retry and confirmed handset was near ens.With assistance the pt had ens discovery button pressed and held and stated led light started flashing.Following this the pt reported getting message that the device (b)(6) is not setup properly for pt use.The pt stated when they first set up their device on friday they showed the pt how to work external devices, but the pt never did anything with it because they were told they should not need to.The pt reported they think they messed something up with it when they changed their bandage today and that's when they tried to connect with their ens and they have been getting these messages.The patient also experienced a lead migration, lead moved, or wire moved ¿ their leads became dislodged.The patient was redirected to their healthcare provider to further address the issue.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17089876
• Report Number: 2182207-2023-01033
• Device Sequence Number: 16825173
• Product Code: EZW
• UDI-Device Identifier: 00763000344573
• UDI-Public: 00763000344573
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/08/2023
• Date Device Manufactured: 12/29/2021
• 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 H10...."
• Patient Age: 54 YR
• Patient Sex: Female