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

Model Number 97715

Device Problems High impedance (1291); Energy Output Problem (1431); Overheating of Device (1437); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Positioning Problem (3009)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Burning Sensation (2146); Discomfort (2330); Electric Shock (2554)

Event Date 02/21/2024

Event Type  Injury  

Event Description

Information was received from a consumer via a manufacturer¿s representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that there was a warm sensation around the implanted neurostimulator (ins) battery when there was an increase to the stimulation parameters.Everything started with a sudden incapacity to increase or decrease the stim parameters for the patient with their controller.The manufacturer representative (rep) checked their impedances and saw that the anode of the bipolar that was used to stimulate was very high and not usable.Therefore, the rep tried to change the configuration without using contact 5 (unusable one); it¿s still possible to stimulate around the right area but this heating/hurting sensation around the borders and surface of the battery appears and increases with higher parameters.Nothing in particular occurred to contribute to this issue.The settings were changed, and now it still alleviates the pain but has slightly uncomfortable sensation around the borders of the battery.The issue has not resolved.Additional information was received.Hcp provider confirmed.Cause of heating not confirmed.The heating of the ins did not necessarily occur during recharging.The patient is set to see the doctor on (b)(6) 2024.The manufacturer representative (rep) was able to find another program, but the patient still feels something uncomfortable.It¿s temporary and should not be a definitive solution.Information confirmed with physician account.

Manufacturer Narrative

G2.Foreign: switzerland 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 977a2 , explanted: (b)(6) 2024product type lead product id 977a2 , explanted: (b)(6) 2024 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 the patient felt stimulations/discomfort/burn/heat at the ins.Shocking sensation was noted.The patient had very good coverage of her painful leg (right) and very good relief.However, since (b)(6) 2024 the patient has not been able to change the intensities with her patient controller.The impedance of contact 5 was out of range of 40,000 ohms (and the contact was used for the anode of my bipole), so the rep found another programming as not to use contact 5, which allowed coverage of the area, but no matter what different configuration the rep tested, the patient still felt discomfort at the battery level.Depending on the configuration, it was felt more or less strongly.The rep had the impression that this sensation increased if increased the pulse duration, but the rep was not sure.The problem came on suddenly, and not as a result of any particular event.The heating did not necessarily occur when recharging the ins.On (b)(6) 2024 the leads and ins were replaced.

Event Description

Additional information was received reporting the problem has been solved.The cause was unknown.

Manufacturer Narrative

Continuation of d10: product id 977a290, lot# va2q6nz024 , implanted: (b)(6) 2023, explanted: (b)(6) 2024, product type lead.Product id 977a290, lot# va2q6nz025, implanted: (b)(6) 2023, explanted: (b)(6) 2024, product type lead.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: 18779328
• MDR Text Key: 336331001
• Report Number: 3004209178-2024-05710
• Device Sequence Number: 1
• Product Code: LGW
• 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: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2024
• Date Device Manufactured: 04/26/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female