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	08/31/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient passed away due to likely sudep, not believed to be related to vns.The explanted products were received for analysis but analysis has not been completed to date.No further relevant information has been received to date.
Event or Problem Description
Product analysis was completed on the returned lead.Setscrew mars were seen on the connector pin providing evidence that proper contact between the setscrew and connector pin existed at least once.The overall condition of the returned lead is consistent with condition that exist post explant.Other than typical wear and explant related observations, no anomalies were identified in the returned lead.No further relevant information has been received to date.
Event or Problem Description
Product analysis was completed on the returned generator.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance, or any other type of adverse condition 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: 12561843
• Report Number: 1644487-2021-01371
• Device Sequence Number: 16500862
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/12/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/27/2018
• Device Model Number: 102
• Device Lot Number: 4735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/06/2021; 11/08/2021; 12/21/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 10/28/2021; 12/02/2021; 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2016
• 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: Death
• Patient Age: 34 YR
• Patient Sex: Male