MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B3300542

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Headache (1880); Nausea (1970); Loss of consciousness (2418); Unspecified Nervous System Problem (4426)

Event Date 12/17/2023

Event Type  Death  

Manufacturer Narrative

Section d10 references: product id b32000 lot# 082m19323a implanted: (b)(6) 2023 product type accessory.Product id b31000 lot# 082t19323 implanted: (b)(6) 2023 product type accessory.Product id b3300542m serial# (b)(6) implanted: (b)(6) 2023 product type lead.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 by the nurse practitioner that the patient passed away on (b)(6) 2023.The patient's daughter said the patient had head pain.No other information had been provided as to the cause of death or of any hospitalization after the procedure (stage 1) on (b)(6) 2023. the cause of death was unknown at the time of this report.The manufacturer representative (rep) reported they were still seeking information.Additional information was received from the practice manager stating there was no correlation between the patient's death and the procedure, device, or therapy.Additional information received from the healthcare provider (hcp) reported prior to the deep brain stimulation (dbs) procedure the patient was seen for assessment.The patient had tremors in both the left and right hand which occurred all day.The patient had a history of arthritis, atrial fibrillation, gerd, h/o migraine, hyperlipidemia, mitral valve stenosis, myocardial infarction, gastritis, and osteoporosis.Medications included, aspirin, zyrtec, neurontin, beni car, imitrex, and coumadin.The patient elected to go through with surgery which went ¿perfectly well.¿ post-operatively a ct scan was completed which showed no significant abnormalities or signs of bleeding.The hcp noted surgery gone ¿perfectly well¿ and the patient was bridged on lovenox prior to their surgery, and did not start lovenox right after surgery for fear of hemorrhage or stroke.The patient did have some abnormal movements of the lower extremities which the hcp thought may have been related to zofran so they were given benadryl and the movements stopped and the headache resolved.In addition, there were some abnormalities in their blood work following surgery including hemoglobin 9.8, hematocrit 30.0, platelets 113, and rbc 2.95 which were all lower than prior to surgery.The patient was kept overnight and did well with a well-controlled headache and was discharged post-operative day one.Thepatient was instructed to avoid any bending, twisting, pushing, or pulling along with any lifting over 15 pounds.They were to report any erythema, edema, or drainage from the incision site or any temperature greater than 101.The patient was scheduled to return for the second phase of surgery the following week.On (b)(6) 2023 the hcp was made aware the patient passed away.The hcp spoke with the patient¿s family who stated the patient complained of a headache on (b)(6).At that time the patient was awake, nonfocal, able to move both upper and lower extremities, nauseated and was put to bed.When the patient went to check on them, they hadn¿t moved and were unresponsive.An ambulance was called who took them to the emergency room.A ct was performed, and they were told there was a very large acute hemorrhagic stroke; they did not recommend surgical intervention, but if they did move forward with surgical intervention, the patient would be hemiplegic and in a nursing home.The patient chose to have the patient extubated and die a natural death.

• Brand Name: SENSIGHT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18747197
• MDR Text Key: 335869949
• Report Number: 2182207-2024-00808
• Device Sequence Number: 1
• Product Code: MHY
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B3300542
• Device Catalogue Number: B3300542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Date Device Manufactured: 10/05/2023
• 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 Outcome(s): Death
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 75 KG