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

Model Number 97715

Device Problems Energy Output Problem (1431); Overheating of Device (1437); Use of Device Problem (1670); Charging Problem (2892); Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); Impaired Healing (2378); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 12/25/2021

Event Type  malfunction  

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

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient (pt) was having the same problems.Pt noted the ins was turned on in november and by christmas they were in tears because they charged their ins battery daily they get an internal burn, pt did not know where the sensation was coming from.The rtm paddle got hot but they could not see any mark on their skin.Pt verified that if they were not using the equipment they could feel the burn from their prior charge and when they go to charge their implant battery again it does not heal and it wasrepetitive and occurred daily.Pt noted even if clothing brushed against the area it hurt.Patient services (ps) was unable to locate case but pt got a new paddle in the beginning of april for their current rtm was their second paddle.  pt had no managing hcp.Pt had not gotten another hcp and their rep knew the pt was looking for a pain management for the last 6 months.Pt sent a text on the3rd of june to their rep informing them that the burn was still there and how they were waiting on referrals for pain management.The rep then sent the pt an attachment and that was it.The trial worked so much better.On 2023-oct-16 information was received from a patient (pt).The reason for call was patient stated they were charging today and got software problem 1 intellis 2 3.0 3 243 4 qf port.Patient reset the controller and was able to continue charging.The troubleshooting steps that were taken on the call resolved the issue.Also issue with an implantable neurostimulator.Patient stated since implant, every time they charge, the area burns.Patient said it feels like the battery is oozing out of their body and it takes forever to find the area to charge.Patient mentioned they have to take the battery out of the controller in order to charge because it wouldn't recharge.Patient service specialist asked patient if they have ever charged with stimulation off and patient said no, but they keep it that way because when they turn the stimulation on it is horrible and they can't cough, sneeze or move and it burns even w hen it is turned off.Patient also mentioned that if they put pressure on the area, it is painful and they cannot sleep.The patient was redirected to their healthcare provider to further address the issue and get a replacement controller.Patient no longer has a managing healthcare provider and no longer sees a manufacturer representative.Patient reported the trial went well and they got 70% of their pain relief but the implant has been nothing but a nightmare.Patient had called before requesting a new representative and no one ever got back to them.Patient noted the representative would come to their house but when they could get ahold of the representative, the representative wouldn't even return the phone calls.

Manufacturer Narrative

Continuation of d10: product id 97755 serial# (b)(6): product type recharger product id 97745 serial# (b)(6): product type programmer, patient 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

A response was received from the patient providing their device serial numbers and clarifying their statement "battery is oozing out of the body" that whenever they charge their battery, they feel a burning sensation at the implant site and further clarifies that it feels as if a lighter is being held at the site of acid is oozing out from inside.Patient also states there were no factors that could have caused the issue, and they always felt this way whenever they charge their battery.Patient also reports their issue has not been resolved, and the 2nd paddle and 2nd charge is always falling out when they try to charge.

• 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: 18140377
• MDR Text Key: 328234347
• Report Number: 3004209178-2023-21277
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2023
• Date Device Manufactured: 01/26/2021
• 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 Age: 60 YR
• Patient Sex: Female