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

Model Number B35200

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Muscle Weakness (1967); Discomfort (2330); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 10/02/2023

Event Type  malfunction  

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

The patient reported that almost immediately after implant date, they noticed that it was "tremendously uncomfortable" whenever they turned the implantable neurostimulator (ins) on.The patient explained that their healthcare provider (hcp) advised them to turn the ins off at night and turn it back on in the morning.The patient likened the discomfort to getting a jolt from a battery, which lasts anywhere from 1 to 5 minutes before their body calms down.The patient added that in the first week of january (of this year), they began to experience weakness in their legs that has gradually gotten worse.The patient mentioned that they reported their leg weakness to a neurologist.The neurologist told the patient they were not experiencing neuropathy, and that their leg weakness was related to the ins.The patient also reported their therapy concerns to their managing hcp and they wanted to set up an appointment to get the ins adjusted, but the hcp refused to adjust the ins and told the patient they have to make the adjustments themselves using the dbs therapy app.The patient's managing hcp also told them to turn the ins on/off more times throughout the day.The patient mentioned that they have been keeping therapy on 24/7 because it allows for better tremor control in their hands, but they still experience weakness in their legs.Agent reviewed role of medtronic as a device manufacturer and redirected the patient to their hcp to further address the issue.

• 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: 18853262
• MDR Text Key: 337130884
• Report Number: 3004209178-2024-06452
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000642174
• UDI-Public: 00763000642174
• 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: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 03/04/2024
• Date Device Manufactured: 08/29/2023
• 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
• Patient Age: 77 YR