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

Model Number B35200

Device Problems Unintended Collision (1429); Malposition of Device (2616)

Patient Problems Dysphasia (2195); Shaking/Tremors (2515); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

B3: date is approximate.Year is confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name sensight; product id b3300542 (lot: va2kflav16); product type: 0200-lead; implant date ; explant date brand name sensight; product id b3300542m (lot: va2kb6rv24); product type: 0200-lead; implant date (b)(6) 2022.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Patient services (pss) received call from patient rep in regards to the patients therapy.The caller stated that in january they found out that the leads were slightly misplaced on the right.The caller stated that they have been going to the healthcare provider (hcp) every month for adjustments and the patient still has a lot of side effects and trouble.The caller stated that the patient leaves the hcp office stable, and by the time they get back home are running again ( back to the way they were ).The caller stated that the manufacturer representative (rep) has helped with programming, three months in a row.The caller stated when they fix one thing, another thing comes up.The caller stated that the patient and speech problems, balance problems , she " runs ", and stated that the patient fell on sunday.The caller stated that the patient has fell a couple of times and has done physical therapy.The caller stated that the patient had their tremor under control but have other symptoms.The caller stated that the hcp told them the patient would be like that without the dbs.The caller stated that they have turned the patient off before, and it happened with sinemet.The caller was wanting to know if there was a referral for a hcp that specializes in side effects of the dbs.Pss reviewed that agent cannot recommend a specific hcp but can share the physician listening with them.The caller stated that the hcp recommend another doctor in san antonio, but they would not be able to get in until january 2025.Pss sent an email to the caller the physical listening and encouraged to talk to the hcp again to further assist.

• 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: 19213705
• MDR Text Key: 341712469
• Report Number: 3004209178-2024-10008
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000519216
• UDI-Public: 00763000519216
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2024
• Date Device Manufactured: 12/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11...
• Patient Age: 77 YR
• Patient Sex: Female