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

Model Number 97716

Device Problems Therapy Delivered to Incorrect Body Area (1508); Low impedance (2285)

Patient Problems Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  malfunction  

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins).Low impedance/short was reported showing 190 and 570 ohms.Impedance check was run using different reference electrodes to see if issue would clear, but issue did not clear.No stimulation issues resulted from the impedance issue.Rep was able to program dtm around impedances and was able to attain good coverage on left side.The cause was not determined.The issue has not yet been resolved.The rep will report additional information that becomes available.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6)2023 explanted: product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6)2023 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: 06-dec-2026, udi#: (b)(6) ; product id: 977a260, serial/lot #: (b)(6), ubd: 16-jun-2027, udi#: (b)(6) 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

Patient (pt) reports stimulation in chest and rib cage as of 3 weeks ago.Hcp notified of issue.Manufacturers representative (rep) spoke with pt on (b)(6) 24 and directed pt to turn stimulation device off.Device will remain off until able to meet with pt.Pt is scheduled for follow up today to meet with hcp and have an updated x-ray taken of leads.No further information is able to be provided at this time.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2023.Explanted: product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2023 explanted: product type lead medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.They reported that they spoke to a manufacturer representative (rep) because the stimulator was not acting right.Pt stated something was wrong.Pt stated they spoke with a rep again at the spine clinic and they did adjustments to their stimulation.Pt mentioned that they asked the healthcare provider (hcp) at this appt to check their leads to see if they were in the right position.Pt stated the hcp did verify that one of the leads was not in the right place.Patient stated they went out of town for a long weekend and they turned the implanted neurostimulators off because they were getting the vibrations in their chest cavity.Pt stated the vibration would get worse when they were laying down.Patient mentioned they had a fusion done on their back almost 2 weeks ago, which was unrelated to the ins/ therapy.Patient stated they are feeling better now that the fusion procedure is over.Suggested that pt contact the hcp office and agent will send an fyi message to the field about pt call.

• 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: 18566171
• MDR Text Key: 333510654
• Report Number: 3004209178-2024-01814
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315474
• UDI-Public: 00763000315474
• 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,Followup
• Report Date: 05/28/2024

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: 12/28/2023
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/28/2024
• Date Device Manufactured: 01/11/2023
• 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...."; "SEE H11...."
• Patient Age: 84 YR