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	Seizures (2063)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient's mother the patient was having an increase in seizures.It was reported that the patient battery was running low.A battery calculation estimated that the battery was likely at eos and no longer stimulating.It was reported that the patient had a battery replacement.The explanted generator was returned.Product analysis was conducted and the device was found to have not reach end of service and was able to provide stimulation.There were no performance or any other type of adverse conditions found with the pulse generator.No additional relevant information has been received to date.
Additional Manufacturer Narrative
H3.Device evaluated by mfr?, evaluation summary attached - correction, device evaluation was inadvertently checked.No evaluation summary was attached in initial mdr.Summary of product analysis was provided in b5 of initial mdr.

• Brand Name: PULSE GEN MODEL 102R
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10289882
• Report Number: 1644487-2020-00964
• Device Sequence Number: 11605696
• Product Code: LYJ
• UDI-Device Identifier: 05425025750023
• UDI-Public: 05425025750023
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 01/30/2019
• Device Model Number: 102R
• Device Lot Number: 203064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Event Location: Other
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR