MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT

Model Number B35200

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Contamination with Chemical or Other Material (2944); Patient Device Interaction Problem (4001)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that the patient complained that when she turned her head to the left, her deep brain stimulation would shock her in the head/neck area. patient said she recently fell, but that the shocking incidents were happening before the fall. pre- and intra-op impedance checks were completed with normal results.The implanted neurostimulator and extensions were replaced.The surgeon visually inspected components during surgery. during the revision/replacement procedure, the neurosurgeon noted brown discoloration on the right lead.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot#: va1nxrz, implanted: (b)(6) 2018, product type: lead.Product id: 3387s-40, lot#: va1nxrz, implanted: (b)(6) 2018, product type: lead.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2022, product type: extension.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2022, product type: extension.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 24-jul-2020, udi#: (b)(4).Product id: 3387s-40, serial/lot #: (b)(4), ubd: 24-jul-2020, udi#: (b)(4).Product id: 3708660, serial/lot #: (b)(4), ubd: 30-nov-2021, udi#: (b)(4).Product id: 3708660, serial/lot #: (b)(4), ubd: 21-nov-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id: 3387s-40, lot#: va1nxrz, implanted: 2018 (b)(6), product type: lead.Product id: 3708660, serial#: (b)(6), implanted: 2018 (b)(6), explanted: 2022 (b)(6), product type: extension.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 manufacturer representatives.The intervention resolved the shocking and the cause of the brown discoloration is not known at this time.

Manufacturer Narrative

Continuation of d10: product id: 3387s-40, lot#: va1nxrz, implanted: (b)(6) 2018, product type: lead, product id: 3708660, serial#: (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2022, product type: extension.Product id: 3708660.H3: analysis of the extension (b)(6) found foreign material at the distal end in the set screw analysis of the extension (b)(6) found the outer insulation of the extension 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.

Manufacturer Narrative

Product analysis # (b)(4) :analysis information -- (b)(6) 2022 09:43:33 cst pli# 30 product id# b35200 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The returned device passed all testing in the laboratory and no anomalies were identified.Continuation of d10: product id: 3387s-40, lot# va1nxrz, implanted: (b)(6) 2018, product type: lead.Product id: 3387s-40, lot# va1nxrz, implanted: (b)(6) 2018, product type: lead.Product id: 3708660, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2022, product type: extension.Product id: 3708660, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2022, product type: extension.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 the manufacturer's representative that the patient had revision surgery due to fall/concuss ion in (b)(6) 2022.It was noted that pre-op impedances still remained normal and no shocking has been present since (b)(6) 2022 revision.

• Brand Name: PERCEPT
• 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: 13546211
• MDR Text Key: 286428503
• Report Number: 3004209178-2022-02151
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000420987
• UDI-Public: 00763000420987
• 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,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2021
• 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 Sex: Female