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

Model Number 97716

Device Problems Disconnection (1171); High impedance (1291); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins).High impedances were reported with electrodes 8-15 above 10k.Lead is showing as disconnected when checking connections.A return of pain was also reported.Rep reprogrammed on 0-7 lead.Patient is happy with pain relief.The cause is unknown and the issue is ongoing.On (b)(6) 2023 additional information was received from the rep.The rep reported the patient reported group a and b did not work anymore, which caused the return of pain, and then the rep discovered the high impedances.The rep could not clarify which lead was showing as disconnected.The pain symptoms have been resolved.

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 section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6), ubd: 08-jun-2024, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(6), ubd: 08-jun-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: 18258954
• MDR Text Key: 329681368
• Report Number: 3004209178-2023-25137
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781740
• UDI-Public: 00643169781740
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2023
• Date Device Manufactured: 07/01/2020
• 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: Male