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

Model Number 97715

Device Problems Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892); Environmental Compatibility Problem (2929); Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Pain (1994); Burning Sensation (2146)

Event Date 11/07/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient was in the er with pain at the pocket site and they believed the ins may be malfunctioning.The hcp stated that everything had been fine since the ins was replaced two years ago and the patient had had occasional hip injections.The caller stated that the patient had a hip injection sometime in october and for the last 5 days the patient had had worsening hip pain, pain at the pocket site and a bruise at the site (patient's wife indicated was unusual).The caller stated that the patient last saw their doctor around 2 years ago, but hadn't seen anyone since then.The caller mentioned the patient had an e-consult in april for their normal chronic pain and they were trying to follow-up with their doctor, but hasn't been able to see them.The caller was transferred to the national answering service (nas) to page a rep.It was also reviewed to have the hcp familiar with the patient's device examine the patient.It was reported that the event began on 2020-11-07.  additional information was received from the hcp the next day (2020-11-13), reported that they had tried to get a hold of the manufa cturer but were unsuccessful.It was again reported that the ins pocket site was black/blue, warm to touch/hot, and hurt.It was indicated that the caller was not with the patient at the time of the call.The patient's wife indicated that there were no falls/traum as/medical procedures that may be related.The patient went to the er yesterday but left against medical advice (ama).It was also reported that their device was not charging and did not show it was charging for 1 week (2020-11-06).Nas number was provided for them to reach out again.Additional information was received from the hcp later the same day reporting that the patient had their settings changed because they were draining the ins, but two days ago the patient started complaining of pain at the site along with  it being black and blue and warm to touch.The hcp stated that the ins wasn't holding a charge and the patient was trying to charge it 4 to 5 times a day.The caller stated that the patient went to the er, but no one was able to help them.The call requested the rep meet with the patient to check the system.The caller was transferred to nas.

Event Description

Additional information was received from the patient's spouse regarding follow-up communication that was received.Caller stated that the patient was still having the same issue; caller states that system problem rm04 appears on the controller three to four times a day when the patient tries to recharge the implantable neurostimulator (ins).Caller states that when the patient unplugs the rtm from the controller, nothing works right and the controller went blank.Patient services (pss) asked the caller if there's any apparent damage to the equipment; caller stated no.When asked if there are any issues with the controller charging from the ac power supply; caller stated no.They stated that sometimes the controller will come on and then shut right down when the patient is trying to recharge the ins with the rtm connected to the controller.It was reviewed that replacing rtm should resolve the issues described above.No symptoms were reported.Additional information was received from the patient.It was reported that they replacement recharger did not resolve the issue.They still had difficulty charging.They thought that they saw a software problem screen, but there were no numbers 1-4 as expected for software problem.No symptoms were reported.It was reported that during the call while attempting a reset, the controller battery pack fell apart into pieces.An email was sent to the repair department to replace the controller and battery pack. .

Manufacturer Narrative

Continuation of d10: product id 97745bp , serial#: (b)(6), product type: accessory, 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.

Manufacturer Narrative

Continuation of d10: product id 97745bp, serial# (b)(6), product type: accessory; product id 3708140, serial# (b)(6), product type: extension; product id 3708140, serial# (b)(6), product type: extension; 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

See h10.

Manufacturer Narrative

Product id; 97715; serial# (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.Analysis found the implantable neurostimulator (ins) passed functional testing.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 device was replaced on (b)(6) 2021.

Manufacturer Narrative

Continuation of d10: product id: 97745, serial# (b)(6), product type: accessory.Product id: 3708140, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2021, product type: extension.Product id: 3708140, serial# (b)(6), product type: extension.Product id: 97755, serial# (b)(6), product type: recharger.Product id: 97745, serial# (b)(6), product: type programmer.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): 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: 10954378
• MDR Text Key: 220981808
• Report Number: 3004209178-2020-21233
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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 H10...."; "SEE H10...."; "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male