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

Model Number 97715

Device Problems Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c165, serial# (b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 03-apr-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins).The patient reports that he is not getting any relief from his system.Paresthesia mapping shows that the far left column of his surgical lead produces paresthesia in his right ribs/abdomen.Rep was unable to produce any bilateral or left-sides stimulation.¿no external factors contributed.However, advancing the lead during implant was difficult.The healthcare provider (hcp) reported that patient had obstructions in the center of his epidural space that made it difficult to place the lead midline.¿lead mapping done (b)(6) 2021.¿the lead will be surgically revised.The issue is not yet resolved.

Event Description

Additional information was received from the patient reporting that their device does not help with pain.They went to the doctor and spoke with the rep.The patient was being scheduled to remove the device.

Manufacturer Narrative

Continuation of d10: product id 977c165 lot# 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.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; ceiba norte industrial park; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; ceiba norte industrial park; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 11717151
• MDR Text Key: 247041138
• Report Number: 3004209178-2021-06585
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2022
• Date Device Manufactured: 06/01/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 104 KG