MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Seizures (2063); Cognitive Changes (2551)

Event Date 04/02/2020

Event Type  Injury  

Event Description

It was reported that patient was being replaced due to an increase in seizures the patient was experiencing.Implant card was received for patient stating that reason for replacement was prophylactic.Explanted generator will not be returned due to hospital policy.Programming history database was reviewed.No additional relevant information has been received to date.

Event Description

Explanted generator is being returned for product analysis.Explanted product has not been received to date.

Event Description

Additional information was received that the patient was experiencing cognitive changes along with the increase in seizures previously reported.The physician attributed the increase in seizures to the decreasing battery life of the generator.The physician attributed the cognitive changes to the increase in seizures which were attributed to the decreasing battery life, therefore the cognitive changes is related to decrease in battery life.The explanted generator was received into product analysis and is currently ongoing.No additional relevant information has been received to date.

Event Description

Generator product analysis (pa) was completed and reviewed.The electrical tests performed in the pa lab found that the generator was at an intensified follow up indicator (ifi) = no condition.The battery voltage was measured at 2.966 volts, and the memory locations on the generator indicated that 68.884% of the battery had been consumed.In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the 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 generator, and the generator performed according to functional specifications.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10001268
• MDR Text Key: 189625693
• Report Number: 1644487-2020-00628
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2015
• Device Model Number: 105
• Device Lot Number: 3688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Event Location: Other
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR