MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number	102R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Convulsion, Clonic (2222); Suicidal Ideation (4429); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanovas employees 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 malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
Event or Problem Description
It was reported that the patient is having an increase in seizures.Patient also noted to be miserable and expressed suicidal ideation with intentions of taking other people with him if device is not replaced.It was then noted by the physician that the device was disabled and patient will be referred for surgery.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
Additional information was received by the physician that the device was disabled due to the patient unable to tolerate their previous settings in (b)(6) 2023.The patient was then experiencing an increase in seizures above pre-vns baseline levels and was noted to be due to the lack of vns stimulation in (b)(6) 2023, as device had been intentionally programmed off.It was also noted that the expressed suicidal ideation with intentions of taking other with him was due to him feeling miserable.Specifically, he was experiencing an increase in seizures from a lack of vns stimulation.Therefore, the cause of the suicidal and homicidal ideations can be concluded to be lack of vns stimulation.The device was noted to be re-enabled in (b)(6) 2023 and that the patient is tolerating these programmed settings.Along with this, the battery status was found at end of service and patient was referred for generator replacement.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
Additional information was received noting that the patient underwent a battery replacement.Procedure was noted to be for prophylactic reasons.Explanted device has not been received to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102R
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18292114
• Report Number: 1644487-2023-01772
• Device Sequence Number: 20507276
• Product Code: LYJ
• UDI-Device Identifier: 05425025750023
• UDI-Public: 05425025750023
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/14/2017
• Device Model Number: 102R
• Device Lot Number: 203273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 02/02/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/19/2024; 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 62 YR
• Patient Sex: Male