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 Erythema (1840); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare prover (hcp) reported via a manufacturing representative (rep) that the patient had pain and redness at the battery site.The patient had a follow up appointment and it was for the hcp to follow up on the patients battery site possible infection.The rep was told that patient had been prescribed oral and topical antibiotics.The rep spoke with physician and his diagnosis is that a medication that the patient is taking for auto immune diagnosis has potentially caused her body to reject the battery.Patient did not report these symptoms to the physician until two weeks ago.The rep is waiting for physician¿s office to receive lab results to determine if there is infection.Antibiotics prescribed by physician.The issue is not yet resolved.Additional information was reported that the patient is very satisfied with their stimulation therapy.She gets very good pain coverage from the system.She has discontinued use of it for the next few days to keep from having to put the recharger over the battery site until the irritation has resolved.A definite cause has not been determined but the lab results were received today and there is no indication of infection from the lab results.The doctor is requesting that the patient discontinue use of the medication he suspects is causing her body to have a reaction to the battery.He will be following up with the patient wednesday, (b)(6) 2020.The rep spoke to the patient and she said it is improving, but not completely resolved.

Event Description

Rep was able to communicate with patient on (b)(6) 2020 regarding her follow up visit with hcp on (b)(6).The hcp did decide to treat her with antibiotics even though lab results levels were not indicative of infection according to patient.Patient¿s weight information was provided.Overall, patient said symptoms of swelling and tenderness are resolving and the site looks much better.Hcp informed patient that he will continue to follow up with her until symptoms are completely resolved.

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 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: 11014985
• MDR Text Key: 221745598
• Report Number: 3004209178-2020-21945
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 66