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 02/01/2019

Event Type  Injury  

Event Description

Clinic notes were received indicating that a patient's generator was unable to be interrogated.The clinic notes also stated that the patient had a cluster of 12 seizures within 8 hours.The physician attributed both the increase in seizures and failure to program to the generator battery being dead, and the physician referred the patient for a battery replacement due to low battery.At the patient's replacement case it was confirmed that the patient's device was able to be successfully interrogated.Additionally, it was noted that the reason for generator battery replacement was prophylactic.The explanted generator was received by the manufacturer.Product analysis is underway but has not been completed to date.No other relevant information has been received to date.

Event Description

The generator was explanted and returned due to prophylactic replacement.Product analysis was completed, and a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.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.There were no performance or any other type of adverse conditions found with the pulse generator during analysis.No other 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: 8618288
• MDR Text Key: 145368911
• Report Number: 1644487-2019-00948
• 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
• Report Date: 06/21/2019

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: 07/11/2016
• Device Model Number: 103
• Device Lot Number: 4010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• 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