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

Model Number 97715

Device Problem Overheating of Device (1437)

Patient Problems Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2022

Event Type  Injury  

Event Description

Information was received from a manufacturer representative (rep) regarding a patient (pt) who was implanted with an implantable neu rostimulator (ins).It was reported that the patient was feeling heating and burning sensation at pocket site while charging ins.Pt reports it feels like internal heating with lead wire where it connects into ins.Pt is very thin (100 lbs) and petite per caller.Pt says this heating became intense over past week and pt's husband says this has been going on for about 4 months.The agent reviewed checking to see if there have been any ins position changes at pocket site or changes in recharge practice that may be a factor.The agent also reviewed issue with recharger heating at base of paddle and to rule that out as an issue.Additional information was received from a manufacturer representative (rep) regarding a patient (pt) who was implanted with an implantable neurostimulator (ins).The rep reported that they were going to meet the patient on (b)(6) 2022 at their appointment to evaluate the system.They will reach out to the manufacturer to the day of the appointment.This information was also confirmed with a physician/account.Additional information was received.It was reported that the rep met with the patient today (b)(6) 2022 and confirmed the recharger heats up when recharging.The rep also mentioned the controller heats up as well.Patient lost a lot of weight and the rep can see the wires.The impedance check was normal per rep.A replacement recharger was sent to the patient.Additional information was received.It was reported that the ins heating issue was not resolved when the patient received their replacement recharger (rtm).The rep stated patient received the replacement recharger and with replacement, indicated that it feels like the ins is getting very hot af ter 3-4 minutes of recharging.The rep will meet with the patient again to re-evaluate.This was confirmed with the physician/account.The rep stated they (and the healthcare provider (hcp)) saw the patient last week and impedances were good.Caller confirmed that the issue is only when recharging.The agent suggested recharging best practices (using belt, using thin piece of clothing, etc.), imaging to ensure the ins hasn't moved and potentially, moving ins to different location or replacing ins with a non-rechargeable.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the cause of the ins heating during recharge was not determined.The actions/interventions taken to resolve the ins heating during recharge were that the recharging paddle was replaced and the patient has since stopped recharging and has started the process of having the implant scheduled to be explanted.The ins heating during recharge has not been resolved.

Manufacturer Narrative

B3: date of event is month and year valid.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 from the manufacturer representative (rep) reporting the implantable neurostimulator (ins) was explanted on (b)(6) 2022.The rep will be returning the explanted ins for product analysis.

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

H3: analysis of pli# 10, product id# 97715, found significant anomaly.Analysis of product id 977a260, serial# (b)(6), product type lead.Product id 977a260, serial# (b)(6), product type lead, found significant anomaly.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 manufacturer representative (rep) regarding a patient (pt) who was implanted with an implantable neu rostimulator (ins).It was reported that the patient was feeling heating and burning sensation at pocket site while charging ins.Pt reports it feels like internal heating with lead wire where it connects into ins.Pt is very thin (100 lbs) and petite per caller.Pt says this heating became intense over past week and pt's husband says this has been going on for about 4 months.The agent reviewed checking to see if there have been any ins position changes at pocket site or changes in recharge practice that may be a factor.The agent also reviewed issue with recharger heating at base of paddle and to rule that out as an issue.Additional information was received from a manufacturer representative (rep) regarding a patient (pt) who was implanted with an implantable neurostimulator (ins).The rep reported that they were going to meet the patient on (b)(6) 2022 at their appointment to evaluate the system.They will reach out to the manufacturer to the day of the appointment.This information was also confirmed with a physician/account.Additional information was received.It was reported that the rep met with the patient today ((b)(6) 2022) and confirmed the recharger heats up when recharging.The rep also mentioned the controller heats up as well.Patient lost a lot of weight and the rep can see the wires.The impedance check was normal per rep.A replacement recharger was sent to the patient.Information was received.It was reported that the ins heating issue was not resolved when the patient received their replacement recharger (rtm).The rep stated pati ent received the replacement recharger and with replacement, indicated that it feels like the ins is getting very hot after 3-4 minutes of recharging.The rep will meet with the patient again to re-evaluate.This was confirmed with the physician/account.The rep s tated they (and the healthcare provider (hcp)) saw the patient last week and impedances were good.Caller confirmed that the issue is only when recharging.The agent suggested recharging best practices (using belt, using thin piece of clothing, etc.), imaging to ensure the ins hasn't moved and potentially, moving ins to different location or replacing ins with a non-rechargeable.Additional information was received.It was reported that the cause of the ins heating during recharge was not determined.The actions/interventions taken to resolve the ins heating during recharge were that the recharging paddle was replaced and the patient has since stopped recharging and has started the process of having the implant scheduled to be explanted.The ins heating during recharge has not been resolved.Additional information was received from the manufacturer representative (rep) reporting the implantable neurostimulator (ins) was explanted on (b)(6) 2022.The rep will be returned the explanted ins for product analysis.

Manufacturer Narrative

Product analysis #705009721:analysis information 2022-11-15 11:38:55 cst pli# 10 product id# 97715 below is unedited, system generated text based on the analysis finding code(s).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 97755 lot# serial# (b)(6) product type recharger product id 977a260 lot# serial# (b)(6) product type lead product id 977a260 lot# serial# (b)(6) product type lead h3: analysis of the recharger (product id 97755 lot# serial# (b)(6)) found no issues with finding or charging the ins.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411 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: 14602258
• MDR Text Key: 293362139
• Report Number: 3004209178-2022-07201
• 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: Non-Healthcare Professional
• 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: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• 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...."; "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 45 KG