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 Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Pain (1994); Rash (2033); Swelling (2091); Post Operative Wound Infection (2446)

Event Date 01/12/2020

Event Type  Injury  

Manufacturer Narrative

Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp) in a clinical study (sdy) and from a manufacturer representative (rep).It was reported that the abscess was evacuated on (b)(6) 2020 and the event resulted in hospitalization.The patient started having hip pain on (b)(6) 2020 without neurological changes and a spine mri showed the epidural abscess.It was noted that the patient was debilitated and a smoker, which increased the infection risk.A repeat mri on (b)(6) 2020 revealed a small collection of fluid remained and the patient was being followed by infectious disease for treatment.The issue was noted to be ongoing.

Manufacturer Narrative

Other relevant device(s) are : product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 17-oct-2023, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(4), ubd: 17-oct-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient in a clinical study (sdy) who was implanted with a neurostimulator for spinal cord stimulation it was reported that the patient had a wound infection and that during the patient's post op visit (b)(6) 2020 patient had rash around both the lead and generator insertion sites but incisions well approximated.Patient was to use hydrocortisone on rash but not around incisions.Follow up visit (b)(6) 2020 revealed erythema and swelling at both sites with a pinhole sized opening at the generator site.Pus was easily expressed from that site and a total of 7 ml was sent to the lab for culture.Wound culture from both sites grew staph aureus (mssa), negative for fungus growth and blood cultures negative as well.Patient started on ancef and vancomycin.Entire system explanted (b)(6) 2020.Despite removal, debridement and irrigation patient developed an epidural abscess t8 - l1 with cord compression.Neurosurgery took her to surgery for a t8 - t10 decompressive laminectomy for evacuation of epidural abscess it was later indicated that the it was related to the implant procedure.No further complications noted or anticipated.

Manufacturer Narrative

Continuation of d11: product id 977a260, serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead, product id 977a260, serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2020, 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 was received from a healthcare professional (hcp) in a clinical study (sdy).It was reported that the event was resolved without sequelae as of (b)(6) 2020.

• 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: 9711212
• MDR Text Key: 191937490
• Report Number: 3004209178-2020-03343
• 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,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 47