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

Model Number 97715

Device Problems Failure to Charge (1085); Migration or Expulsion of Device (1395); Unintended Collision (1429); Battery Problem (2885); Charging Problem (2892)

Patient Problem Pain (1994)

Event Date 10/03/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id :97755, serial#: (b)(4), product type: recharger; product id: neu_unknow n_lead, serial#: unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received via manufacturer representative (rep) from a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that patient had been trying to charge the ins and she couldn't charge the ins as the controller wouldn't let her go very far at all.She had been trying to troubleshoot the issue, however she couldn't get the ins to charge.She had also fallen and she went to healthcare professional (hcp) today and hcp "took a picture" and that it looked like one of the leads came down and looped over, so she didn't know if that had anything to do with the ins not charging.Patient service specialist (pss) had the patient attempt to recharge the ins and patient was seeing the setup screen on the controller.Pss had the patient select setup for implant.The ins wouldn't charge when she was laying down anymore and she had to sit up and hold the rtm in place with her hand.Before she had fallen she could usually lay in bed withthe equipment and the ins would charge with no problems.Patient was then seeing no device found appear on the controller when trying to recharge the ins.Pss had the patient select recharging instead of try again.She had been through the passive recharge mode (prm) and she couldn't get it to stay there to charge the ins and show the normal charging screen.She could only get the middle number on the trying to charge screen as high as 98 but that the controller wouldn't go to the normal charging screen and the controller would beep, display that the controller needed to be charged and then the controller would shut off.During the call, the middle number on the trying to charge screen was going back and forth between 95, 96, 86, 91, 92, 93, 94 and 76 once when the patient had moved the rtm paddle.She had to bend down to get the middle number higher on the trying to charge screen.Her hand got tired since she had to hold the rtm paddle in place over the ins.She tried using the belt and it didn't work.She had done everything this weekend and it was not doing good at all, so she was in real bad pain.The ins did work when it worked.The first time this issue happened when she was trying to charge the ins, the controller showed the two batteries (cont roller and ins) but the controller battery was orange and the ins battery didn't show hardly any green at all.She did a controller reset and then the controller said to call the manufacturer.The controller displayed looking for device and it kept doing that.She got such pain, so that was why she had to keep moving when trying to recharge the ins.This issue first started maybe a week ago and that it was around the same time that she hadfallen.At hcp's office, she got the middle number on the trying to charge screen in prm up to 97, but then the controller shut off.The controller powered back on after it had shut off.The rep reported that patient stayed with recharger over her ipg at least an hour with no success in recharging her ipg.Images were taken of her ipg and her leads.Her leads did migrate a whole vertebral body down, the rep was not able to check for connectivity as her ipg was depleted and the rep could not connect to it.At time of this report, the issue had not resolved.

Event Description

Additional information was received.It was reported no interventions were being taken to resolve the migrated leads.The physician was waiting to hear from the patient if their ins had been fully charged or was still giving them issues.If the issue persists the physician will revise the leads.X-ray images were taken to see where the leads were currently.Additional information was received.It was reported the patient was sent a new recharger, however the system was still not working.It kept going back to stating looking for device.The patient did get up to 100 and showed two number on one side and a big number.The screen would beep and go off.It would state unable to recharge.

Manufacturer Narrative

Continuation of d11: product id 97755 lot# serial# (b)(6), implanted: explanted: product type recharger product id 977a260 lot# serial# (b)(6), implanted: (b)(6) 2019, explanted: product type lead product id 977a260 lot# serial# (b)(6) ,implanted: (b)(6) 2019 explanted: product type 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.

Manufacturer Narrative

Continuation of d11: product id: 97755, serial# (b)(6), product type: recharger.Product id: 977a260, serial# (b)(6), implanted: (b)(6) 2019, product type: lead.Product id: 977a260, serial# (b)(6), implanted: (b)(6) 2019, product type: 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.

Event Description

Additional information received reported that the patient fell several times after getting a new recharger and tried to revive the ins.

Manufacturer Narrative

Concomitant medical products: product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2019 explanted: product type lead product id 977a260 lot# serial# (b)(6) implanted: 2019-04-18 explanted: product type 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.

Manufacturer Narrative

H3: analysis of the 97715 s/n (b)(6) found was returned for product analysis.The implantable neurostimulator (ins) passed functional testing, there were insignificant anomalies.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 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: 10680558
• MDR Text Key: 211435741
• Report Number: 3004209178-2020-17953
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR