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

Model Number 97715

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Patient Device Interaction Problem (4001)

Patient Problems Electric Shock (2554); Insufficient Information (4580)

Event Date 02/08/2022

Event Type  malfunction  

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

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the stimulation is turning on and off, like it has a mind of its own.Caller stated that they called the mdt rep who recommended they call patient services and request a replacement controller.Caller confirmed that they do not have any issues with the controller neither when using nor when charging the implant.Caller stated that they do not have adaptive stim enabled.Caller stated that it almost seems positional, like they will feel the stimulation in one position but then they will move and it feels like it shut off because they dont feel it anymore.Ps asked caller if in the moments that they do not feel stim, what does the controller show and caller stated that the controller shows stim is still on.Caller confirmed they have not seen any error messages on the controller either.Caller confirmed that the "stim off" is not a situation on implant discharge.Caller stated the have abc groups and it is happening on all of them.Caller stated sometimes they have to increase stimulation as it seems to drop to default settings they are not sure what is happening.Agent did not ask about the circumstances that led to the reported issue.Ps reviewed with caller that what they are de scribing does not appear to be a controller issue and replacement will likely not resolve anything as it appears to be programming related.The patient was redirected to their healthcare provider to further address the issue.Caller mentioned the implant was replaced back in 2017 when they had an issue where they did not feel stimulation.Redirected caller: patient's hcp [related information in pe (b)(4) - ins replacement].

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 received from the consumer via the manufacturer representative reported that the battery was randomly turning off throughout the day during normal use.The device was reprogrammed.Impedances and the controller were checked and all were working fine.The patient was directed to log when they felt the battery shut down so logs could be reviewed.The issue was not resolved at the time of the report.

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

Caller called back so that mdt file can be created as caller seeing pt today.Caller reiterated pt's complaints about stim sensation turning off (stimulator is not turning off per controller).This occurs multiple times/day - sometimes 1-2x/hour or every couple of hours.Pt used to use stim 100% of the time but has started using it less due to the cutting in and out of stim.No cycling or as being used.No falls or traumas.No concerns about lead migration.Impedances all normal range.Pt does notice this more when he goes from sitting to standing or certain movements like pushing on the accelerator while he's driving a car.Pt says stim can feel a little shocky when it does come back on.Caller did reprogram pt on feb 18 but this didn't resolve the issue.Pt mentioned that when the issue started that it started suddenly one day in a random way.Created mdt file and caller will send to tss.Patient reported cau se not determined; hcp checked leads and they seemed to be functioning correctly.New programs were added.Hcp to schedule a time to read battery logs to verify malfunction.

• 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: 13523624
• MDR Text Key: 296316781
• Report Number: 3004209178-2022-01981
• 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
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 02/21/2022; 03/03/2022
• Supplement Dates FDA Received: 02/24/2022; 03/23/2022
• Date Device Manufactured: 11/06/2017
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 86 KG