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

Model Number	353101
Medical Device Problem Codes	Intermittent Continuity (1121); Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993); Data Problem (3196)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 306001, lot#: 60274408, implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: screening device.Other relevant device(s) are: product id: 306001, serial/lot #: (b)(4), ubd: 15-dec-2022, udi#: (b)(4).Date of event.Date is estimated; year is valid.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a basic evaluation trial patient who was using an external neurostimulator (ens) for fecal incontinence.The trial began (b)(6) 2021.It was reported that the patient's therapy had turned off on its own twice, completely zeroing out their stimulation settings.They were able to turn it back on and program the settings at a comfortable level of 1.7 volts.Additional information was received from a healthcare provider (hcp).The hcp reported that the cause of therapy turning off on its own twice, completely zeroing out the patient's stimulation settings was not determined.It was unknown whether or not this issue was resolved.A lead replacement or retrial was planned.The date of surgery was planned for (b)(6) 2021.The current device was removed on (b)(6) 2021.
Additional Manufacturer Narrative
H3: analysis of the ens (s/n (b)(6) revealed that there was no anomaly or functionality failure detected.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
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 12310652
• Report Number: 2182207-2021-01395
• Device Sequence Number: 5002401
• Product Code: EZW
• UDI-Device Identifier: 00643169968783
• UDI-Public: 00643169968783
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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
• Operator of Device: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2020
• 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...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female