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

Model Number 97715

Device Problems High impedance (1291); Unintended Collision (1429); Overheating of Device (1437); Charging Problem (2892); Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); Discomfort (2330)

Event Date 04/10/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c265, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2021, information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that pt states she needs an mri for having pain since she had a fall (b)(6).Patient services (pss) walked pt through mri mode.  the reason for call was pt states she still has pain and on (b)(6) she fell in a store right on the implant.They took x-rays and everything looked fine but she was still having pain.The patient was redirected to their healthcare provider to further address the issue.On 2021-05-14, additional information received from the consumer reported that the pain was improving.They weren't sure if the fall they had caused the pain or if it was something else.It was reported that they had not seen their mri results yet.On 2021-07-13, additional information was received from the patient reporting that they were having trouble with their stimulator.Patient states after the implant she was getting 100% relief but she took a fall in (b)(6) 2021 and since then it feels like she has a heating pad under the stimulator during the day and at night it hurts.Patient stated she saw her doctor after the fall and they did mri and everything seem good.Patient reported she use to charge once a week but noticed she has to charge twice a week this last month.Patient stated after the fall she met with mdt rep end of (b)(6) 2021 to checked her device and she was told the two top leads are not working.Patient stated she called rep this morning but hasn't heard back from him.Patient stated she has adaptive stim and she likes it a lot.Patient stated she has an appointment with her doctor on (b)(6) 2021.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the manufacturer representative(rep) clarifying the report of the ¿top two leads not working after the patient¿s fall¿ meaning that the patient had high impedances found on electrodes 0 and 8.The cause of the high impedances were unknown.It was reported that the rep adjusted the programming to avoid electrodes 0 and 8.It was reported that the rep met with the patient on (b)(6) 2021 and impedances were still high.The patient was still complaining of the hot sensation when using their stimulator.The rep instructed the patient to turn it off and follow-up with their implanting physician.The patient¿s weight at the time of the event was unknown.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.

Event Description

Additional information was received from the manufacturer representative (rep).It was reported that the actions/interventions taken to resolve the ins pocket feeling hot, charging more often was they checked impedances and connectivity, both within normal limits.The actions interventions that took place to resolve the coverage and high impedances was that electrode is not being used, it is being avoided and different electrodes were tried.

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 977c265 lot# serial# (b)(6), implanted: (b)(6) 2021, 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.

Event Description

It was reported that since fall in (b)(6) 2021 the ins pocket is feeling very hot to the patient.The skin of the pocket is very sensitive and tender and hurts sometimes when the shirt touches it.The patient notes the pocket stays about 5 degrees warmer than the rest of her skin according to a thermometer.Rep will program the patient today to see about getting better coverage and review next steps with the physician.She will send the mdt file in for checking as well.Patient noted she is charging more often since the fall.She had been charging once a week but is now charging 3 times a week.Caller checked report and noticed several charging sessions but also reviewed these are showing as good instead of excellent and this could account for longer or more often charging session.Caller reported pairings with contact 0 showing >33000.Caller would like to use contact 0 but will program around it.

Manufacturer Narrative

Continuation of d10: product id: 977c265, serial# (b)(6), implanted: (b)(6) 2021, 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 was received from the manufacturer representative (rep) reporting that the patient had their ins explanted last week.The caller indicated that they would be returning the ins for analysis.

Manufacturer Narrative

H3: product id 97715 serial# (b)(6) was returned for product analysis.Analysis found no significant 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
• 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: 12215372
• MDR Text Key: 263141703
• Report Number: 3004209178-2021-11299
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2021
• 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....".
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female