MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Energy Output Problem (1431)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2018

Event Type  malfunction  

Event Description

Report received that a patient's generator was interrogated in the clinic.An error message was received on the programmer stating "the pulse generator is disabled due to a wand reset".The provider then used another programmer to interrogate the device where it was found that all the output currents were set to 0ma.Further information was received from the provider that there were no actions taken before the generator was interrogated.It was also reported that it was not possible that another provider could have disabled the device prior to the disablement being seen in the clinic.There was no programming history available for review and no additional data has been reviewed to date.The device history record was reviewed and showed that the generator passed all quality inspections and electrical testing prior to being released for distribution.No additional relevant information has been received to date.

Event Description

Internal investigated 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.

Event Description

An addendum internal investigation was performed for the previously reported event.It was determined that dendritic growth was observed on the routed edge of the printed circuit board assembly inside a returned affected generator.It is believed that conductive residues deposited on the edge of the circuit board during the laser-routing manufacturing process likely promoted an environment conducive for dendritic growth to occur between test points on the telemetry and reset circuits.The probable root cause is therefore considered to be related to the laser-routing process.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 7726092
• MDR Text Key: 115362559
• Report Number: 1644487-2018-01298
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2017
• Device Model Number: 103
• Device Lot Number: 4374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2015
• 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: 29 YR
• Patient Sex: Female