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

Model Number 97715

Device Problems Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892)

Patient Problem Pain (1994)

Event Date 03/23/2023

Event Type  malfunction  

Event Description

The patient reported that they had been working with a manufacturer representative (rep) since around (b)(6) 2023 to get settings to help with their pain as well as to get their implanted neurostimulator (ins) charge to last a day.   in (b)(6) 2023, the patient was noticing that it was taking about two hours to charge the ins from 20% charge with excellent recharge quality.   they also reported that on (b)(6) 2024 they noticed that their ins charge had not depleted at all.  they waited until the end of the day on (b)(6) 2024 and it still showed 100% charge.  then, on (b)(6) 2024, the pt switched to another group and left their settings on that group, and checked the ins charge in the evening of (b)(6) 2024, and the ins charge was down to 90%.  it was noted that "was totally wrong".  when the pt spoke with the rep on (b)(6) 2024, the rep told them that the ins should be almost drained by the end of the day, and they redirected the pt to call patient services (pss).  it was noted that prior to the call to pss on february 5, 2024, the pt reset the controller and confirmed that everything was working fine after resetting the controller, but the ins charge was still showing 100%.   pss reviewed that battery depletion is dependent on settings and usage.   the external equipment was assessed by the pt and they confirmed that the controller battery pins and the recharger pins looked fine; they did not see any damage to the equipment.  pss walked the pt through clearing connections.   the pt would continue to monitor charging duration.  the pt was redirected to their doctor to further address the issue of the ins charge not depleting as expected.Additional information was received on 2024-feb-16 by the pt and on 2024-feb-22 by the rep.The rep reported they interrogated the pt's ins on (b)(6) 2024 and performed reprogramming.The pt had reported to them on (b)(6) 2024 that the ins had been depleting within less than 24 hours.They did an energy check that day and based on the intensity level and the pt using the therapy 24/7, the recharge interval was expected to be 2 full days, however on group a that had cycling programmed, the ins was lasting up to 24-30 hours.Then, on february 5, 2024, the pt reported they weren't even getting 24 hours out of the ins, so they contacted patient services for further assistance.The rep reported they requested anterior-posterior as well as lateral x-rays of the leads (it was noted the pt has nevro leads), and the provider determined that the placement of the leads looked correct and confirmed the leads had not moved.As of february 5, 2024 the ins was depleting in less than 24 hours when using groups b and c.Additionally, the pt was not able to get at least 20% pain relief despite several reprogramming sessions over a course of 4-5 months.The pt clarified that the reason they reset their controller on february 5, 2024 was because the controller was taking several hours to charge the ins, and after several hours, it showed that they had used zero battery after 24 hours of use.The pt confirmed that after speaking to the rep on february 6, 2024, the rep had told them to not charge the ins again until the ins charge was down to 20% or "low battery".The pt stated they did this and it took ~5 days to get down to 20% charge.They were able to charge the ins back up to 100% charge.The pt also confirmed that their stimulation was set to on the entire day on feb 3, 2024, when the ins charge had not decreased from 100%.The pt also reported they have never received even 20% pain reduction, so they were extremely disappointed with this product.As of february 16, 2024, the pt was still working with a rep.The rep reported the pt was scheduled to see the doctor on february 29, 2024.The rep will be contacted to obtain an update and clarification on the discrepancy between what they reported and what the pt reported.

Manufacturer Narrative

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 received from the manufacturer representative reported that the doctor had suggested other interventional pain procedures.The patient was going to keep the stimulator off during those treatments to assess the efficacy without any stimulation.If the patient wasn¿t satisfied they would meet with the rep for another reprogramming.It was noted the patient still had to charge 2 times or more a day and was not getting relief.

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.

• 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: 18833921
• MDR Text Key: 337761363
• Report Number: 3004209178-2024-06255
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/26/2024
• Date Device Manufactured: 03/10/2023
• 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
• Patient Age: 58 YR
• Patient Sex: Male