MAUDE Adverse Event Report: MPRI INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97725

Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431)

Patient Problems Pain (1994); Dizziness (2194); Neck Pain (2433)

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977d260, serial# (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: screening device.Product id: 977d260, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 26-may-2025, udi#: (b)(4).Product id: 977d260, serial/lot #: (b)(4), ubd: 27-may-2025, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received via a manufacturer representative from a patient who started a trial of a spinal cord stimulation system on (b)(6) 2021.It was reported that on (b)(6) 2021, the patient experienced a change in stimulation to his right hand, pain and dizzi ness upon standing.The manufacturer representative met with the patient at the clinic on (b)(6) 2021 to attempt reprogramming; however, it was unsuccessful.The physician decided to pull the lead due to possible movement.He then replaced the lead.The patient had good results, but on 2021-jul-29, the patient had severe left sided neck pain described as sharp, shooting pains.The patient returned to the clinic on (b)(6) 2021.Impedances were checked, and they were okay.The clinic pulled the lead under fluoroscopy.The image showed some movement of the lead.These issues have been resolved.

Event Description

Clarification was received from a manufacturer representative reported that the patient received a new wireless external neurostimulator and lead after the first trial lead was pulled on (b)(6) 2021.Refer to manufacturer report # 3007566237-2021-00081.

Manufacturer Narrative

Continuation of d10: product id 97725 lot# serial# (b)(6) product type external neurostimulator product id 977d260 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2021 product type screening device product id 977d260 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2021 product type screening device 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: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 12281389
• MDR Text Key: 265185873
• Report Number: 2649622-2021-15790
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1