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 Convulsion, Clonic (2222); Ambulation Difficulties (2544)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was also reported that the patient has had gradually worsening seizures and difficulty walking since last fall.The physician believes the cause of the increased seizures is due to a loss of stimulation from the generator.The physician does not believe the device was supplying stimulation at the output current it was programmed to.It is unknown whether the increased seizures were above or below pre-vns baseline levels.It was noted that the seizures worsened even though they had been subsided to a certain level when the generator was considered to be working correctly in the past.The physician attributes the walking difficulties to the worsened seizures.The generator replacement was for both the increased seizures and walking difficulties, but the physician did not indicate whether this was for patient comfort or to preclude serious injury.Once the battery was replaced, the patient was able to be interrogated successfully.The explanted generator has been shipped back for product analysis.Internal generator data was reviewed, and confirmed that the generator was supplying stimulation as programmed.The suspect product has not been received by the manufacturer to date.No other relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any defects¿ or malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

The suspect product was received by the manufacturer to undergo product analysis.Analysis has not been completed to date.

Event Description

Product analysis was completed on the returned generator.The device output signal was monitored for more than 24-hrs and a comprehensive automated electrical evaluation was performed.There was no performance, or any other adverse condition found with the pulse generator.There were multiple recorded events of faulted diagnostics, but successful diagnostics were recorded the same day at variously programmed output currents.There were no other anomalies in the generator's internal data.

• Brand Name: PULSE GEN MODEL 105
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16632425
• MDR Text Key: 312435476
• Report Number: 1644487-2023-00372
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2018
• Device Model Number: 105
• Device Lot Number: 203894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 04/06/2023; 05/08/2023
• Supplement Dates FDA Received: 05/01/2023; 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2016
• 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 Age: 13 YR
• Patient Sex: Female