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

Model Number 97715

Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 06/01/2021

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 patient regarding an external device and a implantable neurostimulator (ins) for spinal pain.The reason for the call was that the controller was not working right.It was lighting up and "looked like it's working but doesn't do anything".The patient had been troubleshooting for over a month and met a representative in person who compared their use to a tablet, reset the device, and unpaired the device, all without resolving the issue.A replacement controller was requested.Additional information received from a representative.It was reported that the representative met with the patient and the patient's new controller allowed amplitude change but the patient did not feel the increase in intensity.However, when using the clinician tablet to increase, the patient could feel stimulation changes just fine.The patient was typically at.1 amplitude and.3 would be too much for them.When testing with the controller, they increased all the way to 5.0 and the patient did not feel anything.Additional information was received.The manufacturer representative reported the cause of the issue was unknown.Additional information received from a manufacturer representative.It was reported that the patient's stimulator was implanted for addressing the patient's foot pain which the representative had been able to capture pretty easily.The patient was experiencing the same thing today in the clinic where the patient would feel increases in stimulation made by the tablet but would not feel increases in stimulation made by the controller.They were using single programs in a group.The patient was very sensitive to stimulation and used 0.1, 0.2 and 0.3 depending on their pain needs with 0.3 ma being the highest level of stimulation the patient used.When they made these increases, they were feeling stimulation and just wanted a small amount more (a click or two) to address the pain by using the controller.This is when the patient would realize that they were not feeling an increase in stimulation.The representative kept the pulse width and rate the s ame for all of the patient's programs(80us and 100hz) and adaptive stimulation was not enabled.The patient did not have any intermittency of stimulation or positional stimulation that made them increase stimulation to a really high level.The representative did not perform an impedance test since that could be uncomfortable for patient given their low level of stimulation.The patient was not seeing the "settings not available" message on their controller and no "out of regulations" notifications occurred on the tablet.The representative was going to send in the log files and an engineer would be consulted regarding the data.The representative also noted that they erased all the settings and this did not resolve the issue.No further complications reported.

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the patient's healthcare provider has decided to replace the implantable neurostimulator.

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

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 explanted implant was returned for product analysis and the manufacturer representative (rep) stated the device was not responding to the controller.

Manufacturer Narrative

H3: 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

See h10.

• 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: 12378342
• MDR Text Key: 268499198
• Report Number: 3004209178-2021-13027
• 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
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2020
• 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...."
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female