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

Model Number 103

Device Problems Energy Output Problem (1431); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 08/12/2018

Event Type  malfunction  

Event Description

It was reported that the patient's generator was interrogated and found to be disabled, unintentionally.It was reported that once discovered the patient's generator was able to be programmed back on without any difficulty or malfunction.The disablement was described by the representative as all of the settings being programmed to 0.The patient's generator was checked in (b)(6) 2019 and everything was reportedly operating as expected with the intentionally programmed settings.On (b)(6) 2019 the generator was found to be disabled again and re-programmed back on without difficulty.A review of device history records for the generator shows that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.No further relevant information has been received to date.

Event Description

It was reported that a final interrogation was performed at the patient's programming appointments and that an intentional wand reset was not performed by the facility on the generator.It was reported that the patient could not feel stimulation during the periods of device disablement when output currents were programmed off.The internal data of the generator was reviewed and indicated that the generator was showing 25% battery capacity was remaining; however, the generator's battery voltage appeared to have rebounded after 15% capacity of the battery was used.Hardware reset events were identified on 09/20/2018, 03/11/2019 and 06/06/2019 which caused the generator output currents to be disabled.The first generator reset, based on the therapy time, occurred approximately on (b)(6) 2018.No known relevant surgical intervention has occurred to date.No additional or 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

Internal investigation revealed 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 considered related to the laser-routing process (manufacturing error caused event).

• 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: 8638576
• MDR Text Key: 146077560
• Report Number: 1644487-2019-01015
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2023

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: 10/21/2018
• Device Model Number: 103
• Device Lot Number: 5126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 07/01/2019; 12/21/2020; 05/23/2023
• Supplement Dates FDA Received: 07/24/2019; 01/14/2021; 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2016
• 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: 22 YR