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

Model Number B35200

Device Problems Unintended Collision (1429); Insufficient Information (3190)

Patient Problems Headache (1880); Hematoma (1884); Intracranial Hemorrhage (1891); Concussion (2192); Dysphasia (2195); Insufficient Information (4580)

Event Date 04/26/2022

Event Type  Injury  

Event Description

It was reported that the patient had hit their head on the window in a car accident, right where their leads were located.The air bag didn't go off in the car accident.The patient was now experiencing symptoms that they felt were device related, including headaches, speech that was fast/slurred, feeling like they've had a glass of wine all the time.The patient said that when they got their new dbs battery, their speech had sped up like it was doing currently and their speech had also sped up like it was now in the past when they had their dbs settings increased.The patient had been seen in the emergency room (er) right after the accident and the er didn't tell the patient they had a concussion or hematoma in the head.The patient said they had been told their regular doctor three days later.They went to the hospital and a ct scan was done that showed that the leads hadn't moved.A manufacturer representative (rep) told the patient that it was unlikely that the car accident had caused damage to the leads because the ct scan showed that leads hadn't moved.The patient said they could feel the lead wire and felt like the lead was right in the area of the brain they had sustained the hematoma.Since they were experiencing these symptoms, they knew that something wasn't right with their dbs and wanted their dbs checked.The patient was redirected to their healthcare provider to further address the issue.The patient stated they had their dbs implanted in a clinical trial for depression.They had tried to get a hold of their dbs surgeon about the situation they were in but hadn't received help from the hcp.Prior to the device,  they had depression for 10 years and couldn't hold a job but the dbs changed that to where the patient had their life back.

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40; lot#: va1ez5l; implanted: (b)(6) 2017; product type: lead.Product id: 3389s-40; lot#: va1dbv8; implanted: (b)(6) 2017; product type: lead.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 11-oct-2019, udi#: (b)(4); product id: 3389s-40, serial/lot #: (b)(4), ubd: 11-oct-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• 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
• 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: 14476685
• MDR Text Key: 292736752
• Report Number: 3004209178-2022-06643
• 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: Study,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/23/2022
• Date Device Manufactured: 11/18/2021
• 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): Other
• Patient Age: 52 YR
• Patient Sex: Female