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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Overheating of Device (1437); Malposition of Device (2616); Charging Problem (2892); Connection Problem (2900); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Scar Tissue (2060); Burning Sensation (2146); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 97755 lot# serial# (b)(4), product type recharger, product id 97745 lot# serial# (b)(4), product type programmer, patient 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 non-malignant pain it was reported that they had been having trouble charging the implant.Patient (pt) reported that they had been charging since 6 am, but had only gotten the implant to 60% charge.Pt then said they had gotten a system problem screen (code asked, unknown) a dozen times today already.Pt mentioned they had seen that system problem before, but normally could just clear the screen.Patient services specialist (pss) asked, pt said the charger (pss understood as controller) and rtm had gotten extremely hot today, even when pt had just started charging.Pt did mention they had lost some weight and the implant battery was very close to the skin over the last couple months (see rtg0138354), and the past week or so as well they had really noticed the battery sticking out.Pt said they were currently on recharging excellent, but later in the call started to have trouble getting the rtm connected.Pt did not see any damage to the rtm cord.An email was sent to the repair department to replace the rtm.Pt said the message they see on their controller is "rm03" cannot continue contact medtronic.Pt mentioned past replacements documented in this case; pt also motioned just getting controller and rtm replaced a few months ago (pss unable to find record of controller replacement in cmf).Pt said they spoke with their rep via text message and the rep told them to call ps to get the controller replaced.Pt said that they don't really use their controller often, because they rarely change any of their settings.Pt mentioned that they had reprogramming done, maybe 3 months ago, in june at dr.Ross's office.Pt said that the reprogramming was done to help with how often they were needing to charge their implant.Pt said that they were put on "cycling" and they don't feel the stimulation a lot and they are building up scar tissue; pt said this reprogramming put them down to charging their implant 2x a day.Pt mentioned that they lost probably around 40 lbs since date of implant, so the implant sticks out and could have possibly moved, but the pt wasn't sure; pt said that their doctor hasn't seen them for this but are aware.Pt said that the doctor mentioned maybe needing a revision to be done; pss understood this possible revision to be done due to the amount of weight the pt has lost since implant.Pt said their intensity is at 14.6 and they "keep it at a high rate" but they don't want to "keep it on too high" because they will have to charge their implant more.Pt said that they don't often feel stimulation because the stimulation turns off for a few seconds; pss understood this as the stimulation turns off for a few seconds while cycling and that this is normal for how their therapy is programmed.Pt said that earlier this week they were not feeling stimulation, pt said they used to be able to just be able to "cough" test and they cannot do that anymore; pt said their stimulation was off for no reason.Pt said that their controller was plugged into the wall at the time they saw their stimulation was off, so they weren't even touching the controller.Pt said the same thing happened this morning.Pt said that their implant battery was not depleted and was at 100% this morning when the controller said stimulation was off.Pss had pt reset their controller (see secure notes for serial numbers).Pt said there was no visible damage to the controller or battery pack.Pss sent email to repair to replace the controller.

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.The patient (pt) called back to request shipping information on the replacement recharger (rtm).The pt mentioned that they attempted to charge their implant last night as they had been without stimulation since 6:00 due to not being able to completely charge their implantable neurostimulator (ins).Pt again reported the rtm getting hot to the touch and that they were pinched by the cord because it was kinked.Pt said it could have caught on fire, but clarified that it was not actually on fire and that they did not have any burns on their skin.The pt called back on (b)(6) 2021 reporting that they received the replacement rtm and asked for tracking information for their replacement controller.Additional information was received from a manufacturer representative (rep).The rep reported that there was heat/sparks from the recharger.The rep reported that factors that may have led or contributed to the issue include frequent recharging, needing a new rtm that she already said was en route from the manufacturer.A new recharger cord is being sent to the pt.The rep noted that the issue is resolved.The patient was charging and said both her site and the recharger cord were getting hot.She felt the actual recharger was so hot it would spark.

Event Description

Additional information was received.It was reported, that there were no circumstances that led to the stimulation turning off by itself.Steps taken included, the charging puck and remote were replaced.And had not happened, since replacement.The issue was resolved.

Manufacturer Narrative

Concomitant medical products: 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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain it was reported that they had been having trouble charging the implant.Patient (pt) said today they had been charging since 6 am, but had only gotten the implant to 60% charge.Pt then said they had gotten a system problem screen (code asked, unknown) a dozen times today already.Pt mentioned they had seen that system problem before, but normally could just clear the screen.Patient services specialist (pss) asked, pt said the charger (pss understood as controller) and rtm had gotten extremely hot today, even when pt had just started charging.Pt did mention they had lost some weight and the implant battery was very close to the skin over the last couple months, and the past week or so as well they had really noticed the battery sticking out.Pt said they were currently on recharging excellent, but later in the call started to have trouble getting the rtm connected.Pt did not see any damage to the rtm cord.An email was sent to the repair department to replace the rtm.Pt said the message they see on their controller is "rm03" cannot continue contact medtronic.Pt also motioned just getting controller and rtm replaced a few months ago.Pt said they spoke with their rep via text message and the rep told them to call ps to get the controller replaced.Pt said that they don't really use their controller often, because they rarely change any of their settings.Pt mentioned that they had reprogramming done, maybe 3 months ago, in june at hcp's office.Pt said that the reprogramming was done to help with how often they were needing to charge their implant.Pt said that they were put on "cycling" and they don't feel the stimulation a lot and they are building up scar tissue; pt said this reprogramming put them down to charging their implant 2x a day.Pt mentioned that they lost probably around 40 lbs since date of implant, so the implant sticks out and could have possibly moved, but the pt wasn't sure; pt said that their doctor hasn't seen them for this but are aware.Pt said that the doctor mentioned maybe needing a revision to be done; pss understood this possible revision to be done due to the amount of weight the pt has lost since implant.Pt said their intensity is at 14.6 and they "keep it at a high rate" but they don't want to "keep it on too high" because they will have to charge their implant more.Pt said that they don't often feel stimulation because the stimulation turns off for a few seconds; pss understood this as the stimulation turns off for a few seconds while cycling and that this is normal for how their therapy is programmed.Pt said that earlier this week they were not feeling stimulation, pt said they used to be able to just be able to "cough" test and they cannot do that anymore; pt said their stimulation was off for no reason.Pt said that their controller was plugged into the wall at the time they saw their stimulation was off, so they weren't even touching the controller.Pt said the same thing happened this morning.Pt said that their implant battery was not depleted and was at 100% this morning when the controller said stimulation was off.Pss had pt reset their controller (see secure notes for serial numbers).Pt said there was no visible damage to the controller or battery pack.Pss sent email to repair to replace the con troller.Additional information was received.The patient (pt) called back to request shipping information on the replacement recharger (rtm).The pt mentioned that they attempted to charge their implant last night as they had been without stimulation since 6:00 due to not being able to completely charge their implantable neurostimulator (ins).Pt again reported the rtm getting hot to the touch and that they were pinched by the cord because it was kinked.Pt said it could have caught on fire, but clarified that it was not actually on fire and that they did not have any burns on their skin.The pt called back on (b)(6) 2021 reporting that they received the replacement rtm and asked for tracking information for their replacement controller.Additional information was received from a manufacturer representative (rep).The rep reported that there was heat/sparks from the recharger.The rep reported that factors that may have led or contributed to the issue include frequent recharging, needing a new rtm that she already said was en route from the manufacturer.A new recharger cord is being sent to the pt.The rep noted that the issue is resolved.The patient was charging and said both her site and the recharger cord were getting hot.She felt the actual recharger was so hot it would spark.Additional in formation was received.It was reported that there were no circumstances that led to the stimulation turning off by itself.Steps taken included the charging puck and remote were replaced and had not happened since replacement.The issue was resolved.

Manufacturer Narrative

Continuation of d10: product id 97755, lot# serial# (b)(6), product type recharger product id 97745, lot# serial# (b)(6), product type programmer, patient 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: 12343640
• MDR Text Key: 267309462
• Report Number: 3004209178-2021-12660
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Date Device Manufactured: 08/28/2018
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Weight: 51 KG