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

Model Number 97716

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

Patient Problems Unspecified Infection (1930); Rash (2033); Local Reaction (2035); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a275, lot#: va1lfva023, serial#: (b)(4), implanted: (b)(6) 2021, product: type lead.Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 02-nov-2021, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 03-nov-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins).The reason for call was to ask about component material for leads.The caller indicated that the patient had a lead replaced.The caller indicated that they are concerned that the patient may have had a reaction to the new leads.The caller indicated that the patient has big nodules on the head, over right ear, and swelling under left eye.They "almost look like cysts or abscesses".The caller indicated that the patient had a rash on neck, upper back, and chest on (b)(6) 2021 when the patient had an appointment with the md.The caller indicated that the md took xrays and based on that thinks the issue is a skull pin infection.Troubleshooting was not required.The issue was not resolved through troubleshooting.

Event Description

Additional information was received from the rep and it was reported at the time of the report, the rash was determined to have been mostly resolved.Based on imaging, surgeon determined swelling and nodules due to an infection caused by the skull pins used during the implant procedure.The patient was admitted to the hospital on (b)(6) 2021 for iv antibiotic therapy.Patient still in hospital receiving iv antibiotics with a diagnosis of methicillin- resistant staphylococcus aureus.

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.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11922239
• MDR Text Key: 265801744
• Report Number: 3004209178-2021-08694
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781740
• UDI-Public: 00643169781740
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 75