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

Model Number	102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion, Clonic (2222)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
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 livanova's 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
Clinic notes were received that the patient experienced an increase in seizure frequency and the physician increased the vns' parameters.The physician noted that the battery is no longer working and that the patient needs a vns battery replacement.It was also noted that the patient continues to have frequent seizures, but there has been some improvement since their vns' adjustment.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
An implant card was received reporting the generator was replaced due to battery depletion.The device has not been received to date.
Event or Problem Description
It was reported that the device was returned to the manufacturer for device evaluation.No additional or relevant information has been received to date.
Event or Problem Description
Generator product analysis was approved for the returned generator.The generator was explanted due to battery depletion.The generator was unable to be interrogated.The generator was opened and the measured battery voltage confirmed the generator at an end of service (eos) condition.Other than the event of no communication due to eos, there were no performance, or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 102
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16743786
• Report Number: 1644487-2023-00455
• Device Sequence Number: 6726935
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/27/2016
• Device Model Number: 102
• Device Lot Number: 202938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 04/20/2023; 05/18/2023; 07/03/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/15/2023; 06/12/2023; 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2014
• 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
• Patient Age: 60 YR
• Patient Sex: Female