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

Model Number 37601

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

Patient Problems Abscess (1690); Inflammation (1932); Skin Inflammation (2443); Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot#: va1zb83, implanted: (b)(6) 2020, product type: lead.Product id: 3387s-40, lot#: va1zb83, implanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 3387s-40, serial/lot#: (b)(4), ubd: 19-feb-2022, udi#: (b)(4).Product id: 3387s-40, serial/lot#: (b)(4), ubd: 19-feb-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient had cranial site inflammation.Environmental/external/patient factors that may have led or contributed to the issue include cpap tubes rubbing on incision.Diagnostics/troubleshooting include wound exploration and washout.Intervention/actions include cranial wound revision at the left incision and drainage.Cultures were taken.Physician stated cpap device tubes we re running over cranial site.The issue is reported to be resolved.

Event Description

Additional information was received reporting that the event was related to the implant procedure.There was a blister around left lead incision area that may represent indolent infection.Event resulted in in-patient hospitalization.The patient had abscess and a wound infection.

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 was received indicating the system was explanted on (b)(6) 2020.

Manufacturer Narrative

Continuation of d10: product id 3387s-40, lot# va1zb83, implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type lead product id 3387s-40, lot# va1zb83, implanted: (b)(6) 2019, explanted: (b)(6) 2020, 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

Section d information references the main component of the system, other applicable components are: product id 3387s-40 lot# va1zb83 serial# implanted: (b)(6) 2019 explanted: (b)(6) 2020 product type lead product id 3387s-40 lot# va1zb83 serial# implanted: (b)(6) 2019 explanted: (b)(6) 2020 product type lead product id 3708640 lot# (b)(6) implanted: (b)(6) 2019 explanted: (b)(6) 2020 product type extension product id 3708640 lot# (b)(6) implanted: (b)(6) 2019 explanted: (b)(6) 2020 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.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 indicating the system was explanted on (b)(6) 2020.

• 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: 10373878
• MDR Text Key: 202049496
• Report Number: 3004209178-2020-13573
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 127