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 06/06/2019

Event Type  Injury  

Event Description

The patient reported that they experienced stronger seizures than normal.The patient also believed that their seizure frequency had increased; and a representative reported that the patient had three seizures while in the patient room.Multiple attempts for additional information were made to the patient's following neurologist; however, no further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

Product analysis was completed on the returned generator.The reported increase in seizures could not be evaluated in product analysis; however, proper functionality of the pulse generator and its ability to provide appropriate programmed output currents was verified in product analysis.The device output signal was monitored for more than 24-hours while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the output signal and demonstrated the device provided expected level of output current for the entire monitoring period.Magnet activations performed one inch using spacer block demonstrated the appropriate magnet output for the programmed settings.Diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.No further relevant information has been received to date.

Event Description

It was reported that the patient's generator was explanted due to reported battery depletion.The generator was received by the manufacturer for product analysis; however, product analysis has not been completed to date.No further relevant information has been received 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: 8751322
• MDR Text Key: 149758198
• Report Number: 1644487-2019-01253
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/10/2012
• Device Model Number: 103
• Device Lot Number: 201513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2010
• 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: 47 YR