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

Model Number 97713

Device Problems Intermittent Continuity (1121); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Unauthorized Access to Computer System (3025); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Inflammation (1932); Discomfort (2330); Electric Shock (2554); Insufficient Information (4580)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the ins malfunctioned.It was reported that the ins was causing shocking sensations in her lower back and battery was burning her skin inside and out.

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

The caller stated their rep told them a while back that there was a recall and malfunction on pt's model and year of ins because the device was sending shocking sensations to pt's lower body and stim was meant for their upper body.Caller said about a year ago the ins issues started and said it started with a burning sensation where the ins was and the leads were inflamed constantly which was causing a lot of discomfort.Caller said the device eventually started to burn the pt's skin inside and out, and pt still felt the sensations of the device being on when turned off.Caller then said they pt was only 87 lbs and the "weight requirement" for the ins was 110 lbs.Caller said the rep monitored the device, but that didn't really help and rep was just supporting the pt and eventually told pt to turn the ins off with the issues they were having.But when pt turned off the ins after having stimulation on for 10 years, the caller said something happened to the pt; caller said pt became very paranoid - like schizophrenic type, delusions, dementia and became violent.Caller said the rep told them the ins would not be causing pt's mental health issues, but caller said they start when pt turns the ins off and said they think when pt turned the stimulation off, all the pain the ins was covering up came back and now pt had 10 years of damage and pt's mind and body just shut down.Caller said they believe this was a new symptom of the ins as they said this was "unstudied time" (caller said since the "study" was 5-10 years, pt was beyond that timeframe so they just don't know if this was a new symptom).Caller said pt was now in jail because of whatever happened to pt and they wanted ps to call the jail to advocate for pt having the ins removed/replaced otherwise pt would be charged with something that pt didn't deserve to be charged with.Pss asked, caller said pt does not have a doctor at the jail, and caller said they were not treating pt there, were not treating pt's crps for over a month even though caller has called them and pt had been putting in request slips but the jail wasn't doing anything.Caller said they brought pt to a primary care doctor as the first step in getting ins removed, and that doctor put in a referral for an mri so they could figure out how to have ins taken out, but pt has not had the mri yet.Caller then mentioned when the pt had the ins put in, the doctor could not put the ins in the typical place, so they had to put the ins in the pt's lower buttocks instead.The patient was redirected to their healthcare provider to further address the issue.Pss reviewed ps was not medically trained and would not be able to advocate for an ins removal on pt's behalf.Pss redirected to the pt's hcps for further assistance on the subject.Caller said when they called the jail and they exchanged release of "roi's" they didn't know anything about the pt so they would have to pull reports from the prior physician.Caller mentioned the pt's old hcp was dr.Patel, but they moved away from there.Caller also said mdt made the ins and put out the "recall" so they should be helping with the pt's situation.Caller said they were not blaming mdt, but said they have a lawyer and didn't want to go there, but said mdt would probably be hearing from the lawyer figuring out how to fix the pt's problem since mdt made the ins and caller felt like there was some connection between the solution that mdt could help with.Pss again redirected to hcp and reviewed the caller's call would be documented.

Event Description

Information was received from a healthcare provider (hcp) regarding an implantable neurostimulator (ins).The reason for call was caller stated patient is in a mental health facility and believes hcp's are controlling their device and they feel "impulses" out of nowhere.Caller was not familiar with the system and had limited information as to what was the current status of the system but wasn't aware that patient had any external devices.

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

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 patient (pt).It was reported that the last time the pt had charged their ins was (b)(6) 2021 and also started experiencing the impulses in (b)(6) 2021.The circumstances that lead to experiencing impulses out of no where was that their controller was stolen and got a new controller after meeting with a tech and both thought it was best to keep it turned off.The cause was not determined and the pt is unsure of the steps taken to resolve the issue.The issue has not been resolved at this time.

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

Pt reported that they have the 9-year battery it's time for it to be removed.Pt said they ended up getting hacked.They have impulse ratings and malfunctioning going on and they do know that there are some drones that keep pushing down the the transformation onto their body and onto their leaves and onto their battery has been going on for a while and the impulse reading and when it gets programmed into c it pushes air through the patient and it causes their waist to be moved to have a wave to it people have the online app and their lot numbers were given out to the public and people utilize it and i drive by they wait and then they do it again and pt turn it on and off.

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

Additional information received via email from the patient.The subject line of the email was "cyber attacks from above and ghost attack from side transformation of transportation of matter pixel stolen card and controller and rechargeable belt." the patient reported that they had an ins implanted in (b)(6) 2014 and had been "hit by a cyber attack and possibly gaming telegram amounge my implant." they were being harassed by people that were using their phones, but they "believe telegramming and drones.".

• 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 MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12672359
• MDR Text Key: 277632291
• Report Number: 2182207-2021-01839
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/02/2024

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: 07/14/2015
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 10/21/2021; 03/28/2022; 07/07/2022; 03/20/2024; 03/11/2024
• Supplement Dates FDA Received: 10/21/2021; 03/30/2022; 07/11/2022; 03/25/2024; 04/02/2024
• Date Device Manufactured: 06/19/2014
• 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
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 44 KG