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

Model Number 104

Device Problem Energy Output Problem (1431)

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

Event Date 04/05/2018

Event Type  malfunction  

Event Description

It was reported that a patient¿s generator was found to be disabled and not delivering current due to a wand reset.The patient experienced coughing when the device was re-enabled.Per the reporter, this had occurred previously with the patient¿s generator and when the device was re-enabled the patient experienced coughing as well.It was reported that an error code 382 was seen which corresponds to the message seen for a variety of disablement causes, and there was no known intentional reset of the patient's device.Reportedly, the patient has had no falls or potential trauma to his chest, there has been no surgery of any kind which could have resulted in the reset, and no one else interrogated his vns device.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.A review of exported programming data confirmed that the patient¿s generator had been reset with an estimated date of (b)(6) 2018.After a system diagnostics test was performed, the device performed as expected.An additional interrogation on (b)(6) 2019 indicated another reset occurred as the estimated restart time was on (b)(6) 2019.There were no issues with lead impedance values or any anomalies with battery voltage in the available data.No additional or relevant information has been received to date.

Event Description

It was reported that the generator had reset again.The physician reported that the patient's generator would be replaced due to the reset as the device was "clearly faulty and not reliable." the patient's normal mode and magnet mode output currents were found to be disabled when the device was interrogated.The patient's normal mode and magnet mode output currents were re-enabled prior to the patient leaving the appointment.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

The internal data from the generator was reviewed and interrogation performed on (b)(6) 2019 indicated that the patient's output currents were disabled.Based on the restart time and the therapy time, the reset likely occurred on 05/08/2019.The generator was able to be programmed back on following the interrogation which showed the reset.There were no issues with lead impedance values or the battery voltage within the internal data of the generator.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

Patients generator was explanted.The explanted product has not been received by the manufacturer to date.

Event Description

The explanted product was received by the manufacturer; however, product analysis has not been completed to date.

Event Description

Generator analysis was completed.Review of the ram/flash data downloaded from the pulse generator shows the ¿rtcrestarttime¿ memory location displays a date of ¿07/14/2019 estimated occurrence¿ (explant date (b)(6) 2020) which is different from the date of ¿(b)(6) 2015 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) 2015, which corresponds to the fet recorded date of (b)(6) 2015 from the dhr.This indicates that the device was reset.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.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 the battery, 2.911 volts as measured during completion of test parameter 7.16.10.2 (measured diagvbat) of the final electrical test, shows an intensified follow-up indicator (ifi=no) condition.The data in the diagaccumconsumed memory locations revealed that 44.693% of the battery had been consumed.

Event Description

This complaint was investigated further in which it was discovered that the root cause of the event was related to a manufacturer error.An addendum investigation has been completed and approved.Multiple investigation strategies, including visual examination, long-term monitoring at implant conditions, firmware modification patches, and electrical resistance and capacitance measurements were performed to determine the cause of the resets.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 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.This process explains why resetting generators would function normally after stimulation was enabled and then encounter a subsequent reset at an unpredictable time later.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: 8492020
• MDR Text Key: 141215638
• Report Number: 1644487-2019-00673
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2017
• Device Model Number: 104
• Device Lot Number: 4655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2015
• 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: 45 YR
• Patient Sex: Male