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 Micturition Urgency (1871); Nausea (1970); Chills (2191); Discomfort (2330); Loss of consciousness (2418); Irritability (2421); Intraoperative Pain (2662); Insufficient Information (4580)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

Product id neu_unknown_lead lot# unknown serial# implanted: (b)(6) 2021 explanted: product type lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from an advanced evaluation trial patient who was using an external neurostimulator (ens) for urgency frequency and urge incontinence.The trial began (b)(6) 2021.It was reported that the patient experienced passing out, cold sweats, and almost throwing up from the pain regarding the procedure.Their back was still a bit sore from the procedure as well.They stated they knew to turn down stimulation if it did become too much for them or uncomfortable.There were no device issues nor further patient complications reported at this time.Additional information was received from the patient.They reported that yesterday, (b)(6) 2021, was a horrible day and the urgency was crazy and aggravating.The said they did adjust their stimulation themselves up, then went back down and this did not help with their symptoms.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12020629
• MDR Text Key: 262213133
• Report Number: 2182207-2021-01069
• Device Sequence Number: 1
• Product Code: EZW
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/17/2021

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
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/17/2021
• 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): Other
• Patient Age: 62 YR