MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number B35200

Device Problems Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Device Overstimulation of Tissue (1991); Dysphasia (2195); Foreign Body In Patient (2687); Paresthesia (4421); Insufficient Information (4580)

Event Date 09/14/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), product id: 3389s-40, serial/lot #: (b)(4), 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

It was reported that when patient (pt) had their first ins implanted (on (b)(6) 2018), "the drill went too far" during the implant procedure and the surgeon had to pick fragments of the patient's skull out of the patient's brain.About 3 months after that, the patient noticed that the left side of their body (left hand, left leg, "and so forth") was not being controlled by the therapy, and the right side of their body was being controlled "a little bit." since then, the patient's healthcare provider (hcp) has been trying to adjust the stimulation levels to help control the left side of the patient's body.However, the patient stated that they were not tolerating the stimulation levels in their legs.The patient stated that they had an operation about 3 weeks ago that involved a surgeon pushing the leads further down into the patient's brain to see if that would help to control the left side of their body.The patient stated that they had a follow up appointment with their neurologist yesterday, which involved the hcp "resetting everything" and setting the stimulation level very low.The patient said they tolerated the low level of stimulation better, and the hcp told the patient that they plan on gradually increasing the level of stimulation over time to see how the patient responds.If that plan does not work, the patient mentioned that their hcp will consider doing a third operation with a "new type of leads." the issue was not resolved.

Manufacturer Narrative

D10: product id 37601, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type implantable neurostimulator.Product id 3389s-40, serial# (b)(6), implanted: (b)(6) 2018, product type: lead.Product id: 3389s-40, serial# (b)(6), implanted: (b)(6) 2018, 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 was received as the patient called back and repeated information previously documented regarding having a surgery "redone" in august because they had a problem with the first surgery.The patient said their doctor is in the process of resetting the ins so it will work better.The patient said the ins doesn't work great for them right now, but their doctor has a lot of optimism that they can get the ins set to where they want it.Therapy was on during the call.The patient mentioned that they turn the ins off every night before they go to sleep.

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 received from the healthcare provider (hcp) reported the cause of the issue was a ¿lead issue.¿.

Manufacturer Narrative

Continuation of d10: product id: 37601, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: implantable neurostimulator; product id: 3389s-40, serial# (b)(6), implanted: (b)(6) 2018, product type: lead; product id: 3389s-40, serial# (b)(6), implanted: (b)(6) 2018, 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 was received: it was reported that patient's other reported symptoms were their tongue moved around and it was challenging to pronounce words, with their left leg constantly tingling.Their ins was replaced in 2020 hoping it would resolve their issues.In (b)(6) 2022 they had a surgery to adjust the leads further into the brain and were now in the correct location.On (b)(6) 2023 they underwent diagnostic and were waiting to hear back on the results, but were told the electrical current was likely not in the right position.They said the leads were only functioning out of the top level instead of all three locations.When attempting to increase stimulation their left leg "draws up.".

• Brand Name: PERCEPT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 15451395
• MDR Text Key: 300216697
• Report Number: 3004209178-2022-12052
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000253363
• UDI-Public: 00763000253363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2023
• Date Device Manufactured: 04/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female