MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_ENS_STIMULATOR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 977d260, serial# (b)(4), implanted: (b)(6) 2018, product type screening device.Product id 977d260, serial# (b)(4) implanted: (b)(6) 2018 product type screening device.Information references the main component of the system.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 28-jun-2022, udi#: (b)(4); product id: 977d260, serial/lot #: (b)(4), ubd: 28-jun-2022, udi# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturing representative (rep) regarding a patient with an external neurostimulator.It was reported that trial leads migrated.It was reported that the patient is currently in a trial and noticed some bleeding at the bandage site and presented to the pain clinic to have her dressing changed.Hcp changed the dressing and examined the leads under x-ray after dressing change found the leads had migrated.Lead placement was examined on (b)(6) 2018 following dressing change and found to have migrate lead.One lead tip is the top of t10 and the other is bottom of t9.Leads were securely taped down and patient was reprogrammed to provide much coverage over t9/t10 as possible.The issue was resolved at the time of this report.No surgical intervention occurred or planned.Patient is alive with no injury.No further patient symptoms or complications were reported in this event.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: EXTERNAL NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7778366
• MDR Text Key: 117300824
• Report Number: 3007566237-2018-02411
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 70