MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Output Problem (3005)

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

Event Date 04/22/2019

Event Type  malfunction  

Event Description

It was reported by the tc that an unusual error code was seen with an m1000 that was implanted a year prior.The error code indicated upon interrogation that the generator was deactivated due to error code 6.The error code was obtained upon interrogation with 2 different programmers.The device was turned back on but the autostimulation was not.The data was reviewed and it was determined that the generator had reset approximately a month and a half prior to detection during easter holiday.No obvious anomalies were identified.At the next patient appointment approximately 3 weeks later, the patient's generator was again found to be disabled due to error code 6.Per the session report, the generator had provided normal mode stimulation 15% of the time since the last visit.The generator was programmed to provide 16% normal mode stimulation.Reboot reason of 6 means that a non-maskable interrupt (nmi) occurred.It was determined that out of the possible causes of the nmi only fram (ferroelectric random access memory) bit error or oscillator fault are considered possible causes in this particular case.It should be noted that an oscillator fault may be transient as a result of emi or repeating, due to component failure.The generator's device history records were reviewed.The generator passed final functional and quality specifications prior to release.No further relevant information has been received to date.

Event Description

It was found that the reason for the 2nd error code 6 message was that the first error code message was never cleared since the settings were never explicitly programmed.Although a m1000 generator will turn back on upon system diagnostics/advanced interrogations, a reboot is only cleared after an explicit programming operation has completed.However, even though the error code wasn't cleared, the generator was still re-enabled and working after the first time the error code 6 was seen.The day of the reset, the patient did not go anywhere.No further relevant information has been received to date.

Event Description

Internal investigation identified possible causes of the reset.While no conclusive root cause was identified, a comprehensive review of device design identified several potential root causes.These include rare single bit upset corruption events within the device sram, firmware anomalies that could trigger automatic reset of the device under certain circumstances, or transient hardware faults.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 8764817
• MDR Text Key: 150156234
• Report Number: 1644487-2019-01302
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2021

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: 01/31/2020
• Device Model Number: 1000
• Device Lot Number: 204464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/05/2019
• Supplement Dates Manufacturer Received: 07/11/2019; 10/27/2021
• Supplement Dates FDA Received: 08/05/2019; 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• 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: 51 YR
• Patient Sex: Female