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

Model Number 104

Device Problems Inappropriate or Unexpected Reset (2959); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2021

Event Type  malfunction  

Event Description

During a routine follow-up appointment upon interrogating the patients device, an error message was received which resulted in the patients device being disabled.The patient also reported not being able to feel stimulation for the past month.Design history record review for the generator was performed.The generator passed final functional and quality specifications prior to release for distribution.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.No other relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

Patient underwent generator replacement surgery.The explanted generator has not been received by product analysis to date.

Event Description

The explanted generator was received but product analysis is still underway.

Event Description

Product analysis was completed on the returned generator.The electrical tests performed in the pa lab found that the generator was at an ifi = no condition.The battery voltage was measured at 3.057 volts, and the memory locations on the generator indicated that 33.759% of the battery had been consumed.In the pa lab, 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.Review of the ram/flash data downloaded from the pulse generator shows the ¿rtcrestarttime¿ memory location displays a date of ¿(b)(6) 2021 estimated occurrence¿ (explant date (b)(6) 2022) which is different from the date of ¿(b)(6) 2019 estimated fet occurrence¿ displayed in the ¿rtcoperatoringtime¿ memory location (these dates should match).The ¿rtcoperatingtime¿ (from the pulse generator) shows an estimated fet occurrence on (b)(6) 2019, which corresponds to the fet recorded date of (b)(6) 2019 from the dhr.This indicates that the device was reset while implanted.A root cause for hw reset condition was not determined.Other than the noted event, there were no additional performance, or any other type of adverse conditions found with the pulse generator.

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 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: 12844041
• MDR Text Key: 284281426
• Report Number: 1644487-2021-01609
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/02/2021
• Device Model Number: 104
• Device Lot Number: 205108
• 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: 11/19/2019
• 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: 61 YR
• Patient Sex: Female