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 Code	Convulsion, Clonic (2222)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient has experienced an increase in seizure frequency recently and was referred for a replacement.Patient underwent full revision surgery.The explanted products have not been received by product analysis to date.No other relevant information has been received to date.
Event or Problem Description
Additional information obtained that the surgical facility's policy is to discard all explants, so product return is not expected.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12487730
• Report Number: 1644487-2021-01299
• Device Sequence Number: 4081923
• Product Code: LYJ
• UDI-Device Identifier: 05425025750023
• UDI-Public: 05425025750023
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 12/10/2021

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: 05/15/2017
• Device Model Number: 102R
• Device Lot Number: 4410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male