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

Model Number 97713

Device Problems Energy Output Problem (1431); Overheating of Device (1437); Electromagnetic Compatibility Problem (2927); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Burning Sensation (2146)

Event Date 06/22/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that about a week ago the patient was lying in their bed and felt sudden excruciating pain that felt like their intensity was turned up extremely high (about 5 to 10 times higher than the patient ever had).The patient also felt intense internal heat.The patient walked around their townhouse for 5-10 minutes and the feelings continued and they went outside and the sensations faded.The patient spent the night at a hotel and didn't have the sensations but went home the next day and the sensations returned.The patient thinks their neighbor (who did "extraordinary" things to the patient and other neighbors in the past) caused the sensations with some type of high emi device.Patient services specialist reviewed possible effects that high levels of emi could have on a spinal cord stimulator.The patient denied any recent injuries/traumas.After this situation happened the patient moved out of their townhouse and they have a new pain in the area where the intense pain was.The patient turned their spinal cord stimulator off about a year ago but denied any complications with their medtronic device.The patient has not attempted to connect their external equipment to their ins.The patient needs to have a mri and plans on having their spinal cord stimulator removed so they can have a mri (patient made no allegations against medtronic device).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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain and occipital neuralgia.It was reported that the patient (pt) is having surgery on (b)(6) 2022 to have the entire spinal cord stimulation system removed.Patient stated the ins has not been effective for several years -asked unknown event date.Pt stated they need 2 mri scans.

Event Description

2021-jun-29 rtg0185131 (con): it was reported that about a week ago the patient was lying in their bed and felt sudden excruciating pain that felt like their intensity was turned up extremely high (about 5 to 10 times higher than the patient ever had).The patient also felt intense internal heat.The patient walked around their townhouse for 5-10 minutes and the feelings continued and they went outside and the sensations faded.The patient spent the night at a hotel and didn't have the sensations but went home the next day and the sensations returned.The patient thinks their neighbor (who did "extraordinary" things to the patient and other neighbors in the past) caused the sensations with some type of high emi device.Patient services specialist reviewed possible effects that high levels of emi could have on a spinal cord stimulator.The patient denied any recent injuries/traumas.After this situation happened the patient moved out of their townhouse and they have a new pain in the area where the intense pain was.The patient turned their spinal cord stimulator off about a year ago but denied any complications with their medtronic device.The patient has not attempted to connect their external equipment to their ins.The patient needs to have a mri and plans on having their spinal cord stimulator removed so they can have a mri (patient made no allegations against medtronic device).The patient was redirected to their healthcare provider to further address the issue.From (b)(4) -2022-may-10 rtg0302909, mpxr 953725(con): information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain and occipital neuralgia.It was reported that the patient (pt) is having surgery on (b)(6) 2022 to have the entire spinal cord stimulation system removed.Patient stated the ins has not been effective for several years - asked unknown event date.Pt stated they need 2 mri scans.2022-jun-13, rp (rep): no new information.

Manufacturer Narrative

H3.Analysis found that the implantable neurostimulator (ins) was functional.Analysis identified that there was a breach due to env ironmental stress crack (esc) on the outer insulation of the body of the lead 4.5cm from the distal end.Analysis identified that two conductors were broken in the distal end of the other lead.Continuation of d10: product id 377660 lot# v021236 serial# (b)(6) implanted: (b)(6) 2007 explanted: (b)(6) 2022 product type lead product id 3778-60 lot# serial# (b)(6) implanted: (b)(6) 2007 explanted: (b)(6) 2022 product type lead.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.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

Pss called pt back to let them know as pt requested and pt then said their doctor called them after pt called ps and said the letter was received.Pt said the analysis letter said there was damage to the lead: "analysis identified there was a breach due to an environmental stress crack on the outer insulation of the body of the lead.Analysis identified that conductors 11 and 12 were broken on the distal end of the lead", but didn't say anything about ins damage.Pt said they knew we couldn't tell pt what had caused the damage to their lead or if it was related to the emi interaction previously reported by pt, but wondered if the damage in the analysis would be consistent with any type of emi.Pss consulted with tech after the call and called pt back to review info.Pss also reviewed couldn't say what had caused pt's damage, only that there was damage in the analysis.

Manufacturer Narrative

Product analysis #704476411:analysis information -- 2023-03-10 15:27:51 cst pli# 10 product id# 97713 below is unedited, system generated text based on the analysis finding code(s).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 determined that the implantable neurostimulator (ins) was functional.Continuation of d10: product id 3778-60 lot# serial# (b)(6), implanted: explanted: product type lead product id 377660 lot# v021236 serial# (b)(6), implanted: explanted: product type lead product id 3778-60 lot# serial# (b)(6), implanted: explanted: product type lead.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: SURESCAN
• 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: 12094569
• MDR Text Key: 259265246
• Report Number: 3004209178-2021-10198
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2014
• 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: 60 YR
• Patient Sex: Female