MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number NEU_ENS_STIMULATOR

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id b3300542m serial# (b)(6) implanted: (b)(6) 2021 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: b3300542m, serial/lot #: (b)(6), ubd: 17-jun-2023, udi#: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that during a stage 1 procedure, after testing and stimulation of the lead, the surgeon attempted to remove the stylet after securing the lead and the stylet had a lot of resistance.They ensured the depth stop on the drive was loosened and not causing tension on the lead and the surgeon attempted to remove the stylet again.After several attempts to remove the stylet, it finally came out but met resistance the entire time it was being removed.The lead was still marked at the same level and secured with the burr hole device.There was no harm or injury to the lead or patient and it remains implanted.The issue was resolved.Additional information was received from the manufacturer representative (rep) reporting the cause was not determined.Additional information received from a rep indicated this was a unilateral case.A 14 mm perforator was used to create the hole.No countersinking was performed.The clip was placed parallel to the screws as the lead was to be tunneled to the side.It was noted that the centering tool was used and the screws were quickly engaged using the centering tool barrels/guides.The lead appeared centered in the burr hole device.It was noted that while removing the stylet the surgeon took the stylet out a little bit and encountered some resistance, they then stopped removing it and confirmed the depth stop was loose.The surgeon then continued to pull on the stylet but the stylet was difficult to remove over the entire length.It was further noted that there was quite a bit of pull needed to remove the stylet.The rep noted the stylet was bent but not kinked.The bend was not at a localized spot, rather there was a gentle curve throughout much of the stylet.Prior to installing the depth stop, the depth stop was moved out a bit then fully inserted to be flush with the end of the lead, this was performed by a scrub nurse.

• Brand Name: EXTERNAL NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 19154194
• MDR Text Key: 341247128
• Report Number: 2182207-2024-02363
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2024
• Initial Date FDA Received: 04/22/2024
• 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
• Treatment: "SEE H11...."
• Patient Age: 62 YR
• Patient Sex: Female