MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 05/02/2019

Event Type  Injury  

Event Description

Clinic notes received for the patient indicated that there were no issues with the device but the physician speculates that there might be a device issue as the patient is having an increase in seizures.The patient was referred for generator replacement.Further information was received that the physician had no assessment of the cause of the increase in seizures and that the patient was referred for replacement as the physician felt the newest device features would be better suited for the patient.Further information was received that the physician did not have an assessment of pre-vns seizure baseline levels.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Generator product analysis was completed.In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.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.The generator was confirmed to be at ifi (intensified follow-up indicator)=no condition.There were no performance of any other type of adverse events found with the pulse generator.

Event Description

Patient underwent generator replacement surgery.Explanted generator was received by product analysis.Product analysis has not been completed to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8739345
• MDR Text Key: 149348489
• Report Number: 1644487-2019-01217
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/17/2011
• Device Model Number: 103
• Device Lot Number: 2495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 07/09/2019; 08/16/2019
• Supplement Dates FDA Received: 07/26/2019; 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR