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

Model Number B35200

Device Problems High impedance (1291); Energy Output Problem (1431); Application Program Problem (2880); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2023

Event Type  malfunction  

Event Description

It was reported that the patient had worsening/return of parkinson's symptoms starting the evening of oct-7th.The patient used the patient programmer (pp) to increase the stimulation therapy.However, it was not possible and there was an "out of range - ins was not able to increase therapy" alert message.In the meantime, the patient's doctor increased their drug therapy to alleviate their symptoms.Factors that may have led or contributed to the issue included that on oct-7th, the patient slightly hit their neck where the extensions were located with the car door.The day before, they had traveled by plane.During follow-up on oct-18th, the neurologist found high impedance on electrode 2 - segments 2b and 2c, which was used for stimulation.The manufacturer representative (rep) measured impedances at 1.0 ma and the measurement gave >5k.When they performed measurement automatically, it resulted in red high impedance.Segment 2a and all other impedances were normal/in range.Brainsense feature was on.The neurologist checked the timeline and the graph representing the amplitude of the lfp signals were completely flat and remained flat for the following days until one or two days prior to the follow-up visit.The neurologist decided to program a different electrode (electrode 1) for stimulation.There was no more alert and everything was working well.The patient was able to adjust their stimulation again.Symptoms were well treated and the patient felt good.The issue was resolved.

Manufacturer Narrative

D10.Section d information references the main component of the system.Other relevant device(s) are: product id: b3300542m, serial/lot #: (b)(6).Ubd: 04-nov-2024, udi#: (b)(4).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 stating that there was no issue with sensing/timeline.As anticipated, the timeline seems flat because of the presence of artifacts that made the scale change for the lfp.It was reviewed that due the high impedance, they doubt that any stimulation is actually delivered by the two affected electrodes.This is in line with the symptoms worsening reported by the patient after the accident with the car door.If the two segments will be used, the ins will be most likely in oor, causing a rapid drainage of the battery.At the end of the session, the group b, in which the segments in the level two are excluded, was activated.This is a good way to prevent the fast drainage while giving optimal therapy to the patient.

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.

• 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: 17993398
• MDR Text Key: 326358791
• Report Number: 3004209178-2023-18180
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2023
• Date Device Manufactured: 09/13/2021
• 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 H10...."
• Patient Age: 57 YR
• Patient Sex: Male