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

Model Number B35200

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Erosion (1750); Unspecified Infection (1930); Impaired Healing (2378); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2023

Event Type  Injury  

Event Description

It was reported that the burr hole is not closing and wires are exposed.Healthcare provider (hcp) knows about issue and is working with plastics team to correct.Hcp stated may need graft may or need to be removed.The wound is not healing from the implant site.Antibiotics and creams have been tried but the wound is still not closing.Working to get patient in with the plastic surgery team.The issue has not yet been resolved.Additional information was received from the manufacturer representative confirming the leads are exposed and wires are showing.The wound did not heal.Burr hole is intake but skin not closing around device.Surgical intervention has not been scheduled yet but is planned.Patient is being scheduled to see surgeon.No date yet.

Manufacturer Narrative

Concomitant medical products: product id: b32000, lot#: 082m27121, product type: accessory; product id :b31000, lot#: 082t26521, implanted: (b)(6) 2022, product type: accessory; product id: b3301542, serial#: (b)(4), implanted: (b)(6) 2022, product type: lead; product id: b3301542, serial#: (b)(4), implanted: (b)(6) 2022, product type: lead.Other relevant device(s) are: product id: b32000, serial/lot #: (b)(4), ubd: 28-sep-2023, udi#: (b)(4) ; product id: b31000, serial/lot #: (b)(4), ubd: 22-sep-2023, udi#: (b)(4) ; product id: b3301542, serial/lot #: (b)(4), ubd: 09-feb-2024, udi#: (b)(4) ; product id: b3301542, serial/lot #: (b)(4), ubd: 09-feb-2024, udi#: (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.

Manufacturer Narrative

Continuation of d10: product id b32000 lot# 082m27121 product type accessory product id b31000 lot# 082t26521 implanted: (b)(6) 2022: product type accessory product id b3301542 serial# (b)(6) implanted: (b)(6) 2022 product type lead product id b3301542 serial# (b)(6)implanted: (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.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

Dditional information received from the manufacturer¿s representative (rep) who reported the patient had wound care surgery on (b)(6) 2023 to skin graft cover the burr hole area that was open and not healing.The plastic team helped close the wounds and the patient was home and recovering.The patient told the rep they were healing and doing well.The devices were not removed, and therapy was back on and working.

Manufacturer Narrative

Continuation of d10: product id b32000 lot# 082m27121 serial# implanted: explanted: product type accessory product id b31000 lot# 082t26521 serial# implanted: (b)(6) 2022, explanted: product type accessory product id b3301542 lot# serial# (b)(6), implanted: (b)(6) 2022, explanted: product type lead product id b3301542 lot# serial# (b)(6), implanted: (b)(6) 2022, 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.

Event Description

Additional information received from the manufacturer¿s representative (rep) who reported the patient had wound care surgery on (b)(6) 2023 to skin graft cover the burr hole area that was open and not healing.The plastic team helped close the wounds and the patient was home and recovering.The patient told the rep they were healing and doing well.The devices were not removed, and therapy was back on and working.(b)(6) 2023, mpxr 1018953 update (rep): additional information received from the manufacturer¿s representative (rep) reported the patient had wound care surgery on (b)(6) 2023 performed by the plastics team where their wounds were closed, and the patient was healing well.There were no other issues as of today.

Manufacturer Narrative

Continuation of d10: product id b32000, lot# 082m27121, explanted: product type accessory product id b31000, lot# 082t26521, implanted: (b)(6) 2022, explanted: product type accessory product id b3301542, serial# (b)(6), implanted: (b)(6) 2022, explanted: product type lead, product id b3301542, serial# (b)(6), implanted: (b)(6) 2022, 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.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the patient¿s scalp didn¿t fully heal, although there were no open wounds.The patient had an appointment with plastic surgery to perform a skin graft over both burr holes, but they were told to get their diet in order to improve her ¿qnc number¿ to help with healing.

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.

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 manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the patient was still having issues with the burr holes not closing.The patient was working with a plastic surgeon to close them but their a1c levels are too high for surgery, and they had not been able to get them into an acceptable range.

• 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: 16216638
• MDR Text Key: 307816206
• Report Number: 3004209178-2023-00897
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000519216
• UDI-Public: 00763000519216
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2024
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2023
• Date Device Manufactured: 02/08/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female