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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Electric Shock (2554); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), product type: lead, product id: 977a260, serial# (b)(4), product type: lead section.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 20-may-2023, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 20-may-2023, 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.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain indications.It was reported that yesterday the ins began shocking them to death and it hurt.Pt described the incident as the most intense pain they had felt in their life.Pt said they have had a kidney stone the size of a pea they passed which did not compare to the pain they are now experiencing.Pt remarked they thought the leads had came out or something crazy.Pt mentioned they work for amazon, driving a forklift, counting things and lifting up to 50lbs, so they thought they may have twisted their back yesterday but then claimed it's not a back twisting problem.Pt added they have been working in the position with amazon prior to ins implant as well as post so they did not believe the shocking was work related.Pt commented that then sensation occurs when moving a certain way such as when bending or standing in a certain position adding they had to take off work early yesterday due to the pain and was trying to go to work today but could not get ins to charge properly.Pt said the shocking/pain was not in the area of the implant site for the leads or ins battery; they indicated it is to the right of where the internal components are implanted towards the middle area of their right kidney.Pt stated they were unable to turn the ins off because the "box" (controller) displays device can not be found (pt claimed ins was charged when message displayed).Pt said their adaptive stim was off (disabled).Pt denied being exposed to any strong electromagnetic fields recently but mentioned they had a mri earlier this month.Pt commented that they had lost a lot of weight recently making the battery in their back appear a lot looser than it was and also mentioned noticing about 6 months ago the ins battery gets hot while recharging.Pt said they are unable to turn the stimulation off because they would be unable to survive with out their therapy.Pt said they tried to communicate with their local mdt rep today for assistance but their text did not go through.The patient was redirected to their healthcare provider to further address the issue.Pt said they now see a different pain specialist, dr swain, who does implants and is scheduled to see them this coming up tuesday.Patient's hcp office called pt during today's call with pats saying they were going to contact the mdt rep to try to get them in contact to work with patient today.Pt clarified the sensation did not feel like shocking so much but rather if they bend a certain way it is an intense pain which feels like they are getting shocked which did not necessarily mean they were getting shocked.2 call recordings.

• 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: 14642928
• MDR Text Key: 301923599
• Report Number: 3004209178-2022-07397
• 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
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2022
• Date Device Manufactured: 05/28/2019
• 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 Sex: Female