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 Visual Impairment (2138); Anxiety (2328); Shaking/Tremors (2515); Ambulation Difficulties (2544); Cognitive Changes (2551); Dementia (4405); Hallucination (4428)

Event Type  Death  

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

It was reported that the patient's mind really took a turn after they had the neurostimulator implanted.Although the implanted neurostimulator (ins) stopped the patient's dyskinesia, they started getting dementia and were having hallucinations and delusions.Agent asked event date for onset of dementia, hallucinations, and delusions, but the caller's response was unclear.The caller said it was (b)(6) of this year that the patient was at a point where they could no longer be on their own.Eventually, the patient was in a geriatric psych hospital for a little bit due to the hallucinations and delusions.Leading up to the patient's death,  the patient had an overnight hospitalization due to what they thought were panic attacks.For at least a month leading up to the patient's death, the patient had a lot of problems with their eyes -the patient could not open them any longer.The caller stated that the patient's dementia caused them to not accept care any longer.The caller did not know if the ins caused the patient's death, but they alleged that the patient's dementia was caused by the ins, and that the dementia was what led to their death.The patient's relevant medical history included that the ins procedure was only done on one side because it would have been too much surgery for the patient to get both sides done.Other relevant medical history included that the patient was diagnosed with parkinson's because they had neurological issues associated with parkinson's.The caller mentioned that the patient did not have a lot of tremors, but they did freeze and shuffle.They also suspected that the patient had lewy body dementia.

• 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: 15321197
• MDR Text Key: 298895284
• Report Number: 3004209178-2022-11053
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/30/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/30/2022
• Date Device Manufactured: 04/21/2021
• 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; Hospitalization; Death
• Patient Sex: Female