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

Model Number 97715

Device Problems Break (1069); Difficult to Remove (1528); Battery Problem (2885)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient was going to have a lead revision soon and then the battery will be active all the time.The battery was depleting when the stimulation was not on.The battery depleted from fully charged to fully depleted in 4 weeks with the ins was turned off.Additional information confirmed that the depletion was normal and the ins was working as expected.In regards to the revision surgery.The patient developed a new pain issue in a different area and had a successful trial with a lead in the new location and then proceeded to an implant of the lead.The previous device had two leads in it covering both right and left hips.The patient only required the lead for the left hip.Due to the fact that the patient had two devices already implanted a decision was made by the physician to remove the lead that was never in use and implant a new lead placed in a different location.The replacement surgery occurred (b)(6) 2023.A small portion of the lead was unable to be explanted due to its location.The new lead implanted, was connected to the existing ins.The new lead was helping with the new pain.

Manufacturer Narrative

Continuation of d10: product id 3877-45.Lot# (b)(6).Implanted: (b)(6) 2023.Explanted: (b)(6)2023.Product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3877-45, serial/lot #: (b)(6), ubd: 05-feb-2024, udi#: (b)(4).G2: australia 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17725231
• MDR Text Key: 323127973
• Report Number: 3004209178-2023-15660
• Device Sequence Number: 1
• Product Code: LGW
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2023
• Initial Date FDA Received: 09/11/2023
• Date Device Manufactured: 03/02/2020
• 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
• Treatment: "SEE H10...."
• Patient Sex: Female