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); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Insufficient Information (3190)

Patient Problems Burning Sensation (2146); Discomfort (2330); Electric Shock (2554)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient reported electrical shock at implant site and excessive heating at battery site, that it felt hot.Rep has checked impedance in 4 different body positions and impedance ranges from 700-1100 ohms.Rep said sensation was not there when therapy was off.Issue appears to be at random.Reviewed possible fluid short, if issue only occurs when therapy is on.Issue started 3 weeks ago.No known cause of the issue, although patient mentioned she has spine fusion procedure in march.Reviewed options with rep if patient is not able to tolerate the sensation at pocket site, such as surgical intervention and it's up to hcp to determine if the neurostimulator needs to be replaced.Troubleshooting was not required.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.

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

Rep reported patient was seen yesterday along with the physician.Patient continues to have burning and stinging sensation at the pocket site.Caller reports the burning and stinging sensation only occurs when patient is charging and stimulation is on, but does not occur when stimulation is off.Patient denies of fall or any traumatic event.Caller reports patient did have a fusion done, unknown specific date.Caller reports patient had her 6 months follow up yesterday.X-ray was done, and the scs system appears to be intact.Impedance were fine electrode 7: 900 ohms range and rest was in the range of 1100 ohms.Rep reports impedance did not change with multiple different position check.Patient was programmed using 0-7 electrode when patient was experiencing burning and stinging sensation.Yesterday reprogramming was done using the 8-15 electrode and did not use 0-7 electrodes.Rep will re-evaluate with patient to see if the sensation resolve.Patient used to charge once a week and now patient is needing to charge every other day.Rep reported when patient charges, patient charges to 100% rep does not know if the charging is related to the sensation.Patient is scheduled for ins battery replacement on (b)(6).

Manufacturer Narrative

H6: the ins has been returned; the coding will be updated once analysis is complete.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 a manufacturer representative and the patient.It was reported that the patient's ins was removed because it was not working.The patient was inquiring about the analysis results.The representative noted that the patient's issue was resolved with the battery replacement.

Event Description

Additional information was received.It was reported the caller had the patient turn off stimulation and press the ins pocket site and the patient did not feel any discomfort.The patient turned stimulation back on and felt discomfort even with pressing on the ins pocket site.The caller reprogrammed the 8-15 lead on the last visit and the burning sensation did not resolve.The patient denied any falls.The x-ray looked good and lead electrodes were lining up with the ins electrode.On 8-19 the caller met with the patient for the first time and patient did not have adaptive stim on.Reprogramming was performed and adaptive stim was turned on.On 9/23 the caller reprogrammed the patient using the 8-15 lead only, discomfort did not change.On 9/23 the patient indicated that stimulation was turning off by itself.Caller reported the ins was not low or discharged.The patient noticed the stimulation was off and had to swipe stimulation back on.The patient was still scheduled for replacement on october 4th.

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

H3: analysis of pli# 10 product id# 97715 found no significant anomalies.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: 12366456
• MDR Text Key: 268099088
• Report Number: 3004209178-2021-12903
• 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,Followup
• Report Date: 09/12/2022

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: 05/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 09/23/2021; 09/28/2021; 10/21/2021; 08/22/2022
• Supplement Dates FDA Received: 09/28/2021; 10/21/2021; 11/02/2021; 09/12/2022
• Date Device Manufactured: 05/29/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female