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

Model Number 353101

Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 309101, lot# unknown, product type: screening device.Information references the main component of the system.Other relevant device(s) are: product id: 309101, serial/lot #: unknown, ubd: , udi#:.(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a trial patient regarding an external neurostimulator (ens).Patient felt pain on the left side and soreness at their incision site.As a result of what was reported, they were advised to call their healthcare provider (hcp).Five days later, the patient's manufacture representative (rep) was notified that the patient cut their leads on their own.The patient was having great results and was ready to move toward implant.They missed their lead pull appointment, but when the hcp's office reached out to them, the patient removed their bandage, noticed the wires hanging down and took it upon themselves to cut them.At the time of this report, the hcp ordered an x-ray for the patient to determine if the wires were removed completely or not.Additional information received from a rep on (b)(6) 2018 who confirmed the information with the hcp.Rep said the patient was instructed to immediately get an x-ray so they could determine if any portion of the lead remained in the body.Additional information was received from the rep on (b)(6) 2018 who obtained the information from the hcp.The patient got an x-ray which confirmed that the leads were inside them.They are still scheduled for implant on (b)(6) 2018, at which point, the leads will be removed.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep).The patient was scheduled for surgery on (b)(6) 2018 as reported previously.The patient did not show up for surgery, and at this point, the healthcare provider's (hcp) office has been unable to reach them to reschedule.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the patient had cut their pne wires during basic evaluation and was scheduled for implant twice and was a no show.The patient was implanted on 8/24/18.During the pre-op interview and confirmed under fluoro at the implant, the patient removed the left pne lead.It was confirmed the right pne lead remained implanted.The patient was implanted with their permanent system and the right pne lead remained implanted.

Manufacturer Narrative

Product id: 309101, lot# unknown, product type: screening device; product id: 305901, lot# unknown, product type: screening device.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep).The rep had called regarding compatibility guidelines for the patient who cut part of their pne lead (the rep reiterated the patient had cut their own pne wire,) when they had their pne trial done.The rep also noted the patient had a successful trial.The rep reported that now the health care physician (hcp) wanted to do an mri of the pelvis and per x-ray there had been some small, maybe an inch left fragments scattered.Mri compatibility was reviewed for the pne lead and abandoned system.There were no further complications reported.

• Brand Name: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7656660
• MDR Text Key: 112994261
• Report Number: 3007566237-2018-01952
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR