MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Headache (1880); Muscle Weakness (1967); Numbness (2415); Insufficient Information (4580)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient exhibited grogginess, some left sided weakness, and a headache in recovery.The patient was evaluated and transferred to a higher level facility as a precaution to investigate further.The rep wasn't sure of contributing factors.The operating procedure seemed to be normal.There were no alarming signs during the procedure.The ins was never turned on, but was programmed temporarily at 0.0 ma.All impedances were within normal limits. the patient had a ct scan on (b)(6) 2021 and an mri on (b)(6) 2021. the ct scan revealed no hematoma at the lead site.The patient was sent to another facility to evaluate for stroke and further care.Additional information was received from a manufacturer representative on 2021-mar-26.It was reported that the cause of the grogginess, left sided weakness, and headaches was confirmed to be due to a stroke.Further actions being taken to resolve the symptoms from the stroke are unknown.The patient is in physical therapy and has since been release.The patient is receiving good coverage for their pain with the implanted stimulator as fo their most recent follow-up visit.The grogginess and headaches have been resolved; however, left-sided weakness and numbness remain due to the stroke.The patient is improving daily.

Manufacturer Narrative

Continuation of d10: product id 977c165 lot# serial#(b)(6) implanted: (b)(6) 2021 explanted: 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.

Event Description

Additional information received.The stroke was not determined to be related to the device or therapy.No medical history was made available.Patient weakness and numbness has remained the same with some improvements.Patient working through physical therapy currently.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11585967
• MDR Text Key: 242912620
• Report Number: 3004209178-2021-05100
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 61 YR