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

Model Number 97715

Device Problems High impedance (1291); Low impedance (2285); Delayed Charge Time (2586); Charging Problem (2892)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2023

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.The patient has had to increase her stim to help cover.As a result the patient is now charging 2x/day.On friday 14th, patient reported having to charge for almost 2 hours and the recharger got warm.She had not noticed this before and noted she was moving around while charging.Caller noted impedance concerns with contact 10->40000 and 4 and 5 were showing "orange".Caller changed programming to avoid these contacts.Patient will use therapy as needed and understands the change in charging time.If the patient notices the warmth recurring she will contact ps for replacement for recharger.On (b)(6) 2023 pt called back stating they were in the hospital for a week for unrelated reasons and after pt got out of hospital they notified the rep in july.Pt was charging twice a day.The rep came to hcp appointment and programmed it twice so that pt did not have to charge twice a day.Pt said they had a lead that was out and a short in 2 of the leads.Pt cannot replace them now due to medical issues.Pt called rep again because it was not controlling pain.Pt and rep were supposed to meet last week but it got rescheduled to meet on the 1st.Then pt has an apt with their hcp on the 16th.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6) , implanted: (b)(6) 2020, explanted: product type lead product id 977a260 lot# serial# (b)(6) , implanted: (b)(6) 2020, explanted: product type lead product id 97755 lot# serial# (b)(6) , implanted: explanted: product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6) , ubd: 20-mar-2024, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(6) , ubd: 20-mar-2024, udi#: (b)(4).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: 18093991
• MDR Text Key: 327654645
• Report Number: 3004209178-2023-19553
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2023

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: 04/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 11/08/2023
• Date Device Manufactured: 04/29/2020
• 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
• Patient Age: 75 YR
• Patient Sex: Female