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

Model Number B35200

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

Patient Problems Memory Loss/Impairment (1958); Dysphasia (2195); Cognitive Changes (2551); Confusion/ Disorientation (2553); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: b3300542, lot#: va2eujlv24, product type: lead.Product id: b3300542m, lot#: va2ee7uv04, product type: lead.Other relevant device(s) are: product id: b3300542, serial/lot #: (b)(4), ubd: 30-jun-2023, udi#: (b)(4); product id: b3300542m, serial/lot #: (b)(4), ubd: 11-jun-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 went to the emergency room for confusion and altered mental status.Their behavior had been affected since dbs surgery.They had short-term memory loss, difficulty finding words, asking where children are who had been out of the house for years, talking gibberish, and had difficulty with hand coordination.Patient states, "something has been wrong; doesn't feel like it's me in my brain." over past couple days, issues since surgery worsened.At one point, he couldn't work his phone and has forgetfulness of things he commonly does or knows.Patient feels there is a disconnect between what he wants to do and how to do it, and the dbs system has not yet been activated.Head ct showed no acute issues but did show more conspicuous edema around right dbs lead than left.Mri is planned.It was stated the patient had in-patient hospitalization.The leads target areas were the stn.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id b3300542 lot# va2eujlv24 serial# implanted: explanted: product type lead product id b3300542m lot# va2ee7uv04 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.

Event Description

Additional information was received: it was reported that the encephalopathy was felt to result from post-surgical changes along with taking clonazepam and marijuana.The patient was advised to stop using marijuana.The issues were resolved on august 06, 2021 without sequelae.

• 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
• MDR Report Key: 12293923
• MDR Text Key: 265588862
• Report Number: 3004209178-2021-12078
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000420987
• UDI-Public: 00763000420987
• 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,study
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR