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

Model Number 97715

Device Problems Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Application Program Problem (2880); Charging Problem (2892); Communication or Transmission Problem (2896); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

Patient Problems Burning Sensation (2146); Electric Shock (2554)

Event Date 11/01/2023

Event Type  Injury  

Event Description

Information was received, from a manufacturer representative.Regarding a patient who was implanted with an implantable neurostimulator (ins).For unknown indications for use.It was reported, that the patient¿s stim was turning off unexpectedly.Impedances were good.Tried to palpate the implanted neurostimulator (ins) in the pocket, no change in impedances.But with stim on, the patient could sense a burning feeling, while palpating.Session report, indicated that the stim was on 100%, but that was in fact not true.Patient was on tonic stim with low frequencies and amp around 4.The patient has kept thorough records of the recent events they had experienced.(b)(6) 2023, the patient woke up in the couch and stim was off.Picture of patient controller confirms ¿stim off¿.Patient could turn it on again.(b)(6) 2023, shocking sensation (unknown, if from stim or not).When checking controller at, stim had turned off.Stim had turned off by itself several times, during the day.(b)(6) 2023, stim turned off several times, during the day (charge was at 50% for both the ins and controller).When at group b, stim just turned off.When changing to group a, it started.Then an error message occurred, during charging that the contact with the ins was lost (connection with implanted device lost).Patient was able to restore that.Patient has counted the period between (b)(6) 2023 and (b)(6) 2023, their stim had turned off unexpectedly 21 times.The pt also, described at some points getting the ¿oor¿ (out-of-regulation)-error message on the patient controller.The pt did experience a fall against the ins pocket soon before these issues began.Additional information was received, regarding communication between the rep and technical services.It was confirmed, that they do not have any session reports without patient data on.And the hospital is not allowed to share reports with patient data on.It¿s possible, that a report without patient data may be gotten on (b)(6) 2024.Palpating the ins with stim to see if this also causes burning or shocking was not done.No signs of infection, no ins charging frequency change.And the patient has seen a return of pain (not sufficient therapy / not receiving therapy 100% of the time).The patient also stated, that they say the oor message once of twice, but not a lot.Screen 75 displayed: recharging ended, and screen 76: poor recharge quality.It appeared when adjusting their therapy.It was also clarified, that the lost connection was not the normal ¿bad connection¿ when charging.There was an actual error code stating, ¿contact with implanted device lost¿.It was confirmed, that the stimulation was off by checking the programmer and the patient¿s return of symptoms.However, the ins battery percentage at those was moment was 50% or above.A patient¿s family member also confirmed, that the stim turned off.The stim does turn off for other programs, not just program b (adaptive stim was programmed, but was turned off).Further ins palpitation and an x-ray were suggested to verify ins position relative to the skin to confirm, it can move within the pocket.Further information was confirmed, with emails from the rep.Event and notified dates were updated, patient info updated, and serial number of ins confirmed.Implant date of ins in 2020, exact date unknown.Cause of the issues is not yet known, still investigating.Impedances were normal.No further actions yet decided, issue has not resolved.Information confirmed, with physician / account.

Manufacturer Narrative

G2.Foreign: sweden.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 a manufacturer representative (rep).It was reported that the cause of the shocking / burning sensation at the ins pocket has not yet been determined.X-rays have been done and there were no abnormalities.The cause of the ins turning off has not yet been determined.The ins is planned to be replaced on (b)(6) 2024 to resolve the issues.The provided information has been confirmed with the physician/account.

Manufacturer Narrative

Implant date is year valid.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

G2.Foreign: (b)(6).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.Regarding the cause of the shocking/burning/ins turning off issues, the rep stated that it was too early to determine, so far since the ins was replaced on (b)(6) 2024, the stim was working without issues.Cause of the sensation will have to be determined by the examination of the explanted ins.Implant date of this ins cannot be confirmed.Ins is set to be returned for analysis on (b)(6) 2024.

Manufacturer Narrative

H3 device evaluation: analysis found that the battery was discharged, so it was recharged, and that the shield/can was scratched, but no significant anomalies were found and the device passed functional testing.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: 18366251
• MDR Text Key: 331358907
• Report Number: 3004209178-2023-26100
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male