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); Overheating of Device (1437); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Burning Sensation (2146); Electric Shock (2554); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

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) for unknown indications for use.The reason for call was pt started experiencing like bad burning sensation in the area where ins is, right next to it, where the leads come out of ins, on the side of it.Pt said "if you look at the ins like it was a clock, it would be at like a 3 o'clock position from the ins".It is almost like electrical sensation, pt said they did not know how to explain it.Pt said 'like a low voltage current'.Pt had no falls/no trauma.Pt reported they had lost some weight and maybe because of that the device was too close to a nerve.Pt said it almost felt like rubbing on the nerve.Pt said the issue started gradually in the last several months and pt had been noticing it more and more.Pt said sometimes they felt the sensation during charging and sometimes not during charging.Pt was driving while on the call and said they could feel the sensation.Pt also mentioned if they use a massager they felt it.Pt confirmed the recharger was not damaged.Asked if pt used the belt or charged over skin.Pt said they charged threw their clothes, they typically sit at their computer chair.Pt said they were 6 ft 4 in.Redirected to hcp to check the device.Pt also mentioned in the last few days they could not check their position, it was not highlighted.Pt tried turning it off and on and tried a reset.Reviewed it was possible that adaptive stim was turned off.Pt agreed they did change the groups.Pt was driving on the call and could not troubleshoot.Reviewed how to ensure that as was turned on.

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 pt.Pt called back saying they have called multiple times about difficulties charging and has been sent multiple rtms.Pt confirmed their issue today was the same ongoing issue as documented in this case.Pt said they met with a manufacturer representative (rep) at the end of last month at healthcare provider (hcp) appointment as pt was having trouble with their unit and talked with rep about charging issues.Pt said rep gave them a spare controller to try (pt put the battery from their controller in rep's controller) and ever since using that controller, they had been able to charge with no issues.Pt also said they no longer had the burning sensation while charging.Pt did not have controller with them and would call back to provide info needed for controller replacement.

Event Description

Pt called in stating they called awhile back about their controller as they were using the medtronic representative's and need a replacement as the rep needs their controller back.Caller states not charging up.Pt states they were told from previous agent that we were shipping out controller however never got any equipment.Pt states their recharger telemetry module (rtm)doesn't work anymore which they noticed last night and needs new paddle because doesn't register when plugged in.Pt doesn't detect damage.Patient services (pss) sent request to repair for rtm and controller.

Manufacturer Narrative

Continuation of d10: product id 97745, serial# (b)(6), product type programmer, patient.Product id 97755, serial# (b)(6), product type recharger.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: 15224940
• MDR Text Key: 297895567
• Report Number: 3004209178-2022-10324
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2023
• Date Device Manufactured: 08/27/2019
• 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: 51 YR
• Patient Sex: Male