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

Model Number 353101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Dizziness (2194)

Event Date 03/10/2023

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) regarding a trial patient who was using an external neurostimulator (ens) for non-obstructive urinary retention.It was noted that the patient¿s trial started on (b)(6) 2023.It was reported that the patient (pt) became light-headed and dizzy the night of the procedure.They fell on their backside, right where the trial procedure was done.They went to the hospital and were treated for pain in that area.They were discharged the following day, but continued to have pain.They were readmitted to the hospital on(b)(6) 2023 with pain in the same area.The pain was across the lower back where the procedure stage 1 as performed.The patient had a lidocaine patch on that area and were still in pain.The hcp made the decision to remove the device and cancel the trial.Stage 1 was removed without complication.The patient will most likely not have another trial.

Manufacturer Narrative

Concomitant medical products: product id: 978b128, lot# va2njjp, implanted: (b)(6) 2023, explanted: (b)(6) 2023, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: va2njjp, ubd: 03-mar-2024, udi#: (b)(4).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: 16564424
• MDR Text Key: 311488326
• Report Number: 2182207-2023-00472
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000640491
• UDI-Public: 00763000640491
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/17/2023
• 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): Hospitalization
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 91 KG