MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Convulsion, Clonic (2222)

Event Date 11/14/2021

Event Type  malfunction  

Event Description

It was reported that a generator had experienced a device reset unexpectedly - programmed to 0 ma.As a result, it did not provide stimulation and the patient experienced an increase in daytime seizures.The manufacturers device history records of the generator were reviewed.The generator passed final functional and quality specifications prior to release for distribution.No further relevant information has been received to date.

Event Description

Internal programming data form the generator was reviewed and showed hardware reset, which was later cleared.Per the data, the generator reset time was on (b)(6) 2021.Impedance and voltage was okay/normal no other anomalies outside of the hardware reset was identified.There was no interrogation of the vns on that date.Internal investigations of similar events reported that while the root cause is undetermined, the issue appears to be related to temporary power loss within the generator related to an unknown hardware failure that may have contributed to an intermittent loss of power.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

Surgery occurred to replace the generator.The explanted generator has not been received for analysis to date.

Event Description

The generator was received for analysis.Product analysis is underway but has not been completed to date.

Event Description

Product analysis was completed and approved on the generator.The generator reset was verified in the lab.In addition, review of the data shows a instance where the hardware reset status did appear 12/15/2021.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Other than the noted event, there were no additional performance, or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

10.Adverse event problem - health effect; corrected information; second supplemental mdr inadvertently omitted replacement coding.

Event Description

An addendum internal investigation was performed for the generator reset.New information was received that dendritic growth was observed on the routed edge of the printed circuit board assembly.It is believed that conductive residues deposited on the edge of the circuit board during the laser-routing manufacturing process.The growth likely created current paths that caused unintended electrical function, which were theorized to burn out, grow back and cause a reset, and burn out again.Therefore the probable root cause is considered related to the laser-routing process.

• Brand Name: PULSE GEN MODEL 104
• 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: 13192087
• MDR Text Key: 284356496
• Report Number: 1644487-2022-00011
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Model Number: 104
• Device Lot Number: 205375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2020
• 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: 47 YR
• Patient Sex: Female