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

Model Number 97715

Device Problems Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Therapeutic Effects, Unexpected (2099); Cramp(s) (2193); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A patient reported that she has had ¿nothing but issues with this one¿ and was getting ready to have some work done with her neurosurgeon on it.The patient noted that her first neurostimulator (ins) was absolutely a dream.The patient wanted basic knowledge of the workings of the equipment.The patient wanted to know the amperage or strength of a component called the paddle.The patient also reported that its ¿immediately causing very bad muscle spasms, so i have to turn it off, that¿s why i need to know theamperage.¿ the patient said this was an internal paddle.The patient was wanting to speak to repair.The patient was going in for surgery on her device and the healthcare provider (hcp) was going to be implanting other parts on her device and wanted to know ¿the strength of the paddle.¿ the patient stated this had nothing to do with the recharger but what¿s going on in her body.The patient later reiterated wanted to know the strength of a ¿paddle¿ because she was getting ready for surgery and the manufacturer¿s representative (rep) w as on vacation.The hcp told the patient he would put a paddle in to get more coverage for the spine.The patient reported that the previous hcp chose to implant the smallest unit and the smallest wire because of the condition of her spine.The hcp believed they might be able to get a bigger wiring.The patient re-reported that she had her first ins for 10 years and it was gift from god; this new one malfunctions, and she didn't know why they wanted to mess with something that was so perfect.The rep told the patient she could increase stimulation to get better coverage, but the patient chose to keep it at 1-3 amps.The patient noted that she was allergic to pain medicine and was dependent on the ins.The patient reported that she felt severe muscle cramping in feet and legs, like having 10 charlie horses at the same time.If the patient turned the ins off, cramping goes away.The patient shuts her ins off and suffers from pain.The patient didn't know what might be causing it.The patient noted that the hcp was scared to operate on her because her spine might collapse.The patient didn't know if the paddle lead would resolve muscle cramping.The patient later reported that she was schedule for surgery on (b)(6) 2020 to replace the lead with the paddle lead.The patient was told the one that she had now was the smallest one and not very strong.The patient asked whether the new lead would have the same strength and how it would be able to cover more area on the spine.The patient reported that since the ins was implanted, she had not gotten a successful response.If the patient kept the ins for the whole day and night and part of the next day, she started having charlie horses.The patient stated that this started within the last year.

Event Description

Additional information received from the consumer reported that they were trying other programming and they have one that works.The paddle was replaced.

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 reported that they were about to have the surgery and it¿s the same issue they had previously.They were asking about "the paddle".Material specifications of paddle surgical lead, length, width, size, and description of the anchor used were reviewed.

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.

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.

Event Description

Additional information was received.It was reported the patient was having the same issue.The patient had tried all three groups a-c and they weren't able to get satisfactory pain relief with them.When the patient increased stimulation high enough to try to cover pain the stimulation would get uncomfortable and described it as feeling residual stimulation in the legs.The patient noted their spine was so severe the device did not cover the pain.The patient had an appointment to adjust their programming.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10684724
• MDR Text Key: 211640997
• Report Number: 3004209178-2020-18034
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention