MAUDE Adverse Event Report: MPRI INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems Unintended Collision (1429); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Audible Prompt/Feedback Problem (4020)

Patient Problems Fall (1848); Inflammation (1932); Pain (1994); Burning Sensation (2146); Dizziness (2194); Discomfort (2330); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported the recharger was getting very hot and burning when patient is recharging.There was no mention of damage to skin from burning or actual burn to skin.The implant and was very slow to recharge.They stated the ins will charge up to 20-40% and it was a very slow charge, was overheating, and burning.Caller stated it was not what it use to be.The recharger made clicking notices.There was no damage to recharger.The issue was not resolved.The patient was getting shocked around the ins area when recharging and it was delivering a shock around the spine.They could not charge the implant properly because of the shocking.The incision area is inflamed and they wanted to pull out the ins.Caller stated she was not sure if something was wrong with the coil or electrodes not being hooked up.They could only charge for 2 minutes because of the shocking.Patient stated everything was meshed together with the shocking of the ins and/or the recharger paddle.The patient said he had couple falls in the last couple days, one fall happened when they were shocked 4 times in 20 minutes, got really dizzy, fell really hard in the bathtub, and got hurt a day ago.The issue was not resolved.

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

The patient's mother called back reporting they received the replacement recharger telemetry module (rtm) and they were still having the same issues as previously reported.When they tried to charge the device they needed to immediately stop because the patient experiences painful shocking; they stated after this shocking they were in pain all day long, and they feel the shocking with stimulation on and off.They confirmed the shocking happens inside the body and they do not think it has to do with external equipment.Tenderness around the implant site was reported.X-rays were taken and the positioning of the internal components looked good.They reported they were going to get another opinion from a different neurosurgeon.

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 was received.It was reported that there were no new circumstances that lead to the shocking from the implantable neurostimulator (ins).The patient noted that the device starts shocking as soon as you start to charge it.To resolve the issue, they tried taking out the battery on the controller and replacing, ordered and tried a new charging coil, tried moving the stimulator battery under the skin, tried different charging placements and nothing works.The event has not been resolved, the patient still cannot charge or use the device.Their pain doctor is clearing them for surgery to have it removed surgically.

Event Description

Additional information was received from the patient's mother.It was reported that the patient's healthcare provider would like to remove the implant battery and they have been consulting and thinking about that decision.

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

Continuation of d10: product id 97755, serial# (b)(6), product type recharger.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 reports that the stimulator was not providing relief for his crps pain.He states that it was helping until approximately 8 months ago.He further reports that at some point the battery was completely depleted and when he attempted to recharge it, it caused him pain at the generator pocket site; therefore, he discontinued using it all together.There were no external factors noted to be contributing to the issue.The patient was seen for reprogramming twice in (b)(6) 2020.Despite the reprogramming sessions, the patient reports ongoing issues that resulted in him seeking explant.The entire spinal cord stimulation system was explanted on (b)(6) 2021.

Event Description

Additional information was received.It was reported the patient's device was explanted on (b)(6) 2021.

Manufacturer Narrative

Continuation of d10: product id: 97755, lot# /serial# (b)(6), product type recharger.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

Continuation of d10: product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2019 explanted: (b)(6)2021 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2019 explanted: (b)(6) 2021 product type lead product id 97791 lot# unknown serial# implanted: explanted: product type accessory product id 97791 lot# unknown serial# implanted: explanted: product type accessory 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

H3: product id# 97715, s/n (b)(6) was returned for product analysis.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.Product id# 977a260, s/n (b)(6) was returned for product analysis.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the all conductors were broken; 25.7 cm from the distal/proximal end of the lead.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.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; ceiba norte industrial park; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; ceiba norte industrial park; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12181860
• MDR Text Key: 261989304
• Report Number: 3004209178-2021-10982
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 109 KG