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

Model Number 37601

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Purulent Discharge (1812); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 07/07/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# (b)(4), product type: extension.Product id: 3708660, serial# (b)(4), product type: extension.Product id: 3387s-40, lot# va1wpms, product type: lead.Product id: 3387s-40, lot# va1xu2j, product.Type: lead.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 02-nov-2022, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 02-nov-2022, udi#: (b)(4); product id: 3387s-40, serial/lot #: (b)(4), ubd: 11-sep-2021, udi#: (b)(4); product id: 3387s-40, serial/lot #: (b)(4), ubd: 26-nov-2021, udi#: (b)(4) if information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had their dbs system removed due to infection.It was also stated that the dbs generator had purulent discharge.The ins was removed, and the pocket was irrigated.It was stated that the patient developed pocket erosion with exposure of the generator on (b)(6) 2019 and the intervention occurred on (b)(6) 2019.They also reported swelling and drainage from a scalp region overlying the leads.Inspection had shown the scalp was revealed and an area concerning for wound breakdown and infection.The decision was made to remove the leads as well.The right lead was able to be pulled out, but the left was stuck at the retro-auricular site, although ultimately removed.The patient tolerated the procedure well.

Event Description

Additional information was received: it was reported that the cause of the lead difficulties was unknown.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 3708660 lot# serial# (b)(6) implanted: explanted: product type extension product id 3708660 lot# serial# (b)(6) implanted: explanted: product type extension product id 3387s-40 lot# va1wpms serial# implanted: explanted: product type lead product id 3387s-40 lot# va1xu2j serial# implanted: 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.

• 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: 9628333
• MDR Text Key: 185494331
• Report Number: 3004209178-2020-01779
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 61