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

Model Number B35200

Device Problems Break (1069); High impedance (1291); Unintended Collision (1429)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  Injury  

Event Description

It was reported that the patient went to see their healthcare provider hcp for a routine visit, and during programming, the doctor told them that one of the leads was reading high and was not conducting any electricity.The patient fell the day before thanksgiving, 2022.The hcp reported investigate impedance on contact 1 and that the therapy was not impacted (no loss of efficacy) because the contact wasn¿t used for programming.No symptoms were reported.No surgical intervention was planned.No actions were taken.The issue was resolved at the time of this report.The patient was told that they could not have an mri due to this.Reviewed mri guidelines and redirected the patient to the hcp.Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported they felt the cause of the high impedance was due to a fall on thanksgiving in 2022.There were no other falls noted and there was no loss of therapy.Additional information received from the manufacturer¿s representative (rep) reported the patient had their entire system explanted.The patient was implanted with a new system, and all went well.The patient was going to be programmed in a few weeks.

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id 3708660, serial# :(b)(6), implanted: 2021 (b)(6), product type: extension product id 3389s-40, lot# va22v9r, implanted: 2021 (b)(6), product type: lead.Section d information references the main component of the system.Other relevant device(s) are: ubd: 07-oct-2024, udi#: (b)(4) ;ubd: 24-jun-2022, 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.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the device was returned due to a fractured lead due to a patient fall.

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id b32000 serial# (b)(6) product type accessory product id 3708660 serial# (b)(6) implanted: (b)(6) 2021 product type extension product id 3389s-40 lot# va22v9r serial# (b)(6) implanted: (b)(6) 2021 product type lead h3.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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

H3.Analysis of the extension (s/n (b)(6) found no significant anomaly as the extension body had been cut through.Analysis of the lead (l/n va22v9r) found the lead body conductor was broken.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: PERCEPT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 17570951
• MDR Text Key: 321403056
• Report Number: 3004209178-2023-14534
• Device Sequence Number: 1
• Product Code: MHY
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2023

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: 08/28/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 08/29/2023; 09/13/2023
• Supplement Dates FDA Received: 09/05/2023; 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2020
• 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: 69 YR
• Patient Sex: Male