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

Model Number 97715

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

Continuation of concomitant products: product id 977a275 lot# serial# (b)(4) implanted: (b)(6) 2021 explanted: product type lead product id 977a275 lot# serial# (b)(4) implanted: (b)(6) 2021 explanted: product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 27-dec-2024, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 27-dec-2024, udi#: (b)(4).

Event Description

Information was received from a manufacturer representative (rep) and healthcare provider (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that patient is not getting relief. tried reprogramming several times. reprogramming was performed and patient sent for xrays.  physician noted that the leads had migrated and that several electrodes were located in the anterior epidural space.

Manufacturer Narrative

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.

Event Description

Additional information was received from the manufacturer representative (rep).It was reported patient tried several options and has decided to turn stimulator off.Doctor told patient to consider other therapy options.

Event Description

Additional information was received from the manufacturer representative (rep).Another reprogramming would be tried to resolve the issue.

Manufacturer Narrative

Concomitant medical products: product id 977a275 serial#(b)(6) implanted: (b)(6) 2021.Product type lead product id 977a275 serial# (b)(6) implanted: (b)(6) 2021.Product type lead 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.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: 12372543
• MDR Text Key: 268303663
• Report Number: 2649622-2021-17438
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2021

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: 03/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 08/26/2021; 09/08/2021
• Supplement Dates FDA Received: 09/08/2021; 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR