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

Model Number 97715

Device Problems Intermittent Continuity (1121); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Battery Problem (2885); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.Continuation of d10: product id neu_unknown (serial: unknown); product type: 0217-unknown; implant date n/a; explant date n/a.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's representative regarding an external device.The reason for call was the pt had have nothing but problems for it was not working.The pts therapy was shutting off going into mri mode starting a couple weeks ago and was doing it more than once, they called their rep about it and had them try to reset the controller but that did not work.Now if they shut off the therapy it would not turn on for sometimes it would work or not work.Agent asked to clarify that statement and they said that regardless of turning the stimulation on and off or not; it will go into mri mode on its own and it's not working either way and they would not feel tingling even when increasing intensity, now the pts back was to point where they could not walk since they were in a lot of pain since even with the stimulation on they were not feeling anything no matter how they turn it up on abc for it was not working.About 3 weeks ago the pt was feeling shocking and had to shut it off.Caller noted they had to wait a long time to get in touch and the rep thought the pt felt just intense tingling but it was shocking and jolting; it only did that one day.They talked 2 or 3 times and wanted it out since it's not working for them but the pain doctor said since the implant (ins) was not in long to call the rep.They worked with it and it worked for shorts period of time but it was not working at all even after going to see the rep and get it adjusted.They would get it adjusted then come home for a couple days then it would not work again.Since they got the ins reprogrammed every time the ins would not last as long when they get it reprogrammed.The pt was lost and did not know what to do since they will get it reprogrammed and it would work for a few days then not working again.The pt could not walk due to pain and it was happening more and more.Caller mentioned rtg0512691 stating the pt had a problem with remote and got a new one but the controller battery door cover would not close.They noted that with the other controller they could flip the battery but with this one they could not, agent reviewed the controller battery did not flip.Agent emailed repair requesting a controller battery door cover and redirected caller to the hcp and rep for further issues.

Manufacturer Narrative

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.

Event Description

Patient's daughter called and repeated previously documented information.The patient (pt) felt the ins hadn't been working, or would only work on and off.Pt couldn't walk or even fold clothes and sometimes had to sit or lay down due to intensity of pain.Caller said pt had continued to work with a rep named kelly for further programming, but then pt felt the ins would drain faster and take longer to charge up.Agent reviewed information and redirected to their hcp to consider imaging, to make sure ins placement hadn't possibly shifted or something, since pt felt the ins had worked for them earlier.

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 was received from the manufacturer representative (rep).It was reported that the cause of the stimulation turning off has not been determined.Patient has an appt today.The patient reported the shocking occurred when patient went to laydown after lifting a rug.Rep recommended turning the stimulation down.The patient/daughter reported turning the intensity down resolved the shocking.The stimulation turning off has not been resolved.

• 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: 18494494
• MDR Text Key: 332679630
• Report Number: 3004209178-2024-00650
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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: 07/18/2023
• 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
• Treatment: SEE H10...
• Patient Age: 67 YR
• Patient Sex: Female