MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage, Cerebral (1889); Loss of consciousness (2418); Cognitive Changes (2551)

Event Date 06/06/2020

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3387-40, lot#: va21sst, implanted: (b)(6) 2020, product type: lead; product id: 3387-40, lot#: va21sst, implanted: (b)(6) 2020, product type: lead; product id: 3708660, lot#: nkn218954v, product type: extension; product id: 3708660, lot#: nkn218854v, implanted: (b)(6) 2020, product type: extension.Other relevant device(s) are: product id: 3387-40, serial/lot#: (b)(4), ubd: 14-aug-2023, udi#: (b)(4); product id: 3387-40, serial/lot#: (b)(4), ubd: 14-aug-2023, udi#: (b)(4); product id: 3708660, serial/lot#: (b)(4), ubd: 20-nov-2023, udi#: (b)(4); product id: 3708660, serial/lot#: (b)(4), ubd: 15-nov-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient received a full set of deep brain stimulation therapy due to meige syndrome on june 4th.The surgery was successful.On june 6th, the patient suffered acute cerebral hemorrhage in the ward and was rescued.The patient was still in observation in the icu.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: : product id 3387-40 lot# va21sst implanted: (b)(6) 2020 product type lead product id 3387-40 lot# va21sst implanted: (b)(6) 2020 product type lead product id 3708660 lot# nkn218954v product type extension product id 3708660 lot# nkn218854v implanted: (b)(6) 2020 product type extension h6: with additional information, the correct fdc code should be 67.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

Section d information references the main component of the system and other applicable components are: : product id 3387-40 lot# va21sst serial# implanted: (b)(6) 2020 explanted: product type lead product id 3387-40 lot# va21sst serial# implanted: (b)(6) 2020 explanted: product type lead product id 3708660 lot# nkn218954v serial# implanted: explanted: product type extension product id 3708660 lot# nkn218854v serial# implanted: (b)(6) 2020 explanted: 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 representative (rep).It was reported that the patient had no autonomous consciousness from june 6 to the present, and the patient is currently in a vegetative state.Family of the patient is going to enter the litigation stage, requesting waive fee expenses of surgical consumables, icu stay fees and filing a claim.

Manufacturer Narrative

B2: included life threatening.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: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10138184
• MDR Text Key: 196808259
• Report Number: 3004209178-2020-10054
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Device Lot Number: NKG740813H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 54 YR