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

Model Number 97714

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Chest Pain (1776); Device Overstimulation of Tissue (1991); Shock (2072); Electric Shock (2554)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c165, serial# (b)(4), implanted: (b)(6) 2020, product type:lead.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that stimulator wont shut off and keeps turning on and up is going up on its own and he cannot turn off or down.Pss tried to walk through remote and to use the recharger the issue was not resolved through troubleshooting.Pss tried to turn off adaptive stim as well however pt ended call.The patient was redirected to their healthcare provider to further address the issue.Pt ended call and stated he will walk across the street and get help.Pss tried to attempt to shut down however no luck.  (mdt rep) reported patient w/ a shocking / jolting sensation when bending over.Patient also experienced the shocking in another instance.This was reported on see mpxr 873048.Caller reported impedances - connectivity test was bad, however, all electrodes with electrode 0 were good.(see attached).Caller looked at the impedance grid in the session report and no electrodes were below 700 ohms.We discussed troubleshooting.Focus on programmed electrodes, and palpating.Caller has additional troubleshooting to perform.Patient is in office, actually in car, and is unable to bend his legs to come out of the car due to his spasticity.Unknown what can be done today due to this condition.Caller prefaced the call to report meeting w/ the patient last wednesday, and patient was reprogrammed and provided adaptive stim.Adaptive stim was disabled after the shocking sensation, due to thinking it may be due to high settings patient was using, and the change in position.However, after disabling adaptive stim the patient had another shocking sensation.Rep reported patient had shocking sensation when lifting a box at work and when turning adaptive stim off at home.Patient's wife doesn't know of any immediate falls but said he has had falls off and on over the past year. impedance check, connectivity check were done. patient felt like the stimulator increased in intensity all of a sudden while picking up a box at work yesterday morning.He thought it was his adaptive stim.It took him several minutes to turn off his stimulator.I offered to meet patient right away but he wanted to go home and lay down.I called his wife yesterday afternoon to follow up around 4:00pm.She was on her way home from work and wanted to try to turn the adaptive stim off using his remote instead of coming into meet me at the hospital since they lived so far away.When she turned his stimulator on in order to turn adaptive stim off he felt a sudden increase in intensity.He described it as a shocking sensation.Patient and his wife then agreed to meet me at the hospital so i could turn his adaptive stim off and decrease the intensity without having to turn the stimulator on.Once at logan regional hospital and starting to interrogate the ipg, michael stated he was having chest pain in addition to his back pain.His wife grabbed a wheelchair and took him to the emergency department where they did a full workup.While in the ed the physician asked rep to interrogate his pain pump.Rep checked the logs and they were bolus requests but no other logs of any concern.Rep then interrogated the ipg, ran connectivity check and got all green.Rep turned off patient's adaptive stim and zeroed out the intensity for each position.Rep turned intensity for group b to zero.Rep ran an impedance check which came back within normal limits.Rep ran different connectivity checks in between the staff working with patient.Most came back all green but two did come back with mostly red.Rep advised patient's wife to leave the stimulator off until rep or they are able to discuss it with pain physician, dr.(b)(6).

Event Description

The physician isn¿t sure if the patients other health issues was playing a factor or if there¿s an issue with the stimulator.Cause not determined.Hcp is referring the patient to a neurosurgeon to potentially schedule a revision surgery if the cause is not determined.The patients wife wants to let her husband rest and calm down for an unknown time before we try to troubleshoot any further.Issue not resolved at this time.

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

Concomitant medical products: product id 977c165 serial# (b)(6) implanted: (b)(6) 2016 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.

Event Description

Additional information received.Rep reported they were notified yesterday morning that the physician was doing a replacement of the ins.He decided during surgery to replace both the lead and the ins to ensure the patient had a new system.After surgery the patients wife told me on sunday the ins was depleted and at zero but he still felt the shocking sensation and that it has happened a couple of times since we met at dr.(b)(6) office.

Manufacturer Narrative

H3: analysis of product id# 97714 found stim ins/battery/not in new condition and analysis of product id 977c165; serial# (b)(6); implanted: (b)(6) 2016; product type lead found stim lead/body/outer insulation/melted.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: 12415298
• MDR Text Key: 272566708
• Report Number: 3004209178-2021-13304
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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
• Report Date: 09/22/2022

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: 12/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 09/03/2021; 10/18/2021; 09/01/2022
• Supplement Dates FDA Received: 09/17/2021; 11/09/2021; 09/23/2022
• Date Device Manufactured: 01/26/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 95 KG