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

Model Number 1000

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); Protective Measures Problem (3015)

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

Event Date 01/09/2020

Event Type  malfunction  

Event Description

It was reported that the patient presented in clinic and her device was unable to be interrogated over the course of 2 hours.A second tablet was used after an hour of troubleshooting on the first tablet but also was unable to interrogate the patient¿s device.A device reset was attempted multiple times but were unsuccessful.Note that the patient reported being able to feel stimulation but after further discussion, it was noted that it was highly possible this was just placebo effect.The tablet data was reviewed and it was verified that the generator was not behaving normally and was in bootloader condition from initial interrogation that appointment.Despite multiple attempts by the tablet to reset the generator, the generator would not reset.A company representative attended an appointment with the patient; however, attempts to reset with an older version of the programmer wand and to collect additional data were unsuccessful.The device would intermittently respond to ¿attention¿ commands, but they were not successful in getting it to accept any subsequent read or boot commands.At the last visit 2 months prior, diagnostics were within normal limits.The device history record of the generator were reviewed.The generator passed final functional and quality specifications prior to release no further relevant information has been received to date.No relevant surgical intervention has occurred to date.

Event Description

The patient's generator was replaced.The suspect product has not been received to date.No further relevant information has been received to date.

Event Description

The suspect product was received for analysis, but analysis has not been completed to date.

Event Description

Product analysis was performed on the returned generator.As received, the generator battery was depleted, which was later found to be due to high current drain.During the m1000 pcba electrical test, the generator failed multiple parameters and did not complete the test.The high current drain was isolated to the generator microprocessor.There was no leakage on any of the pins of the microprocessor.Normal diode break down was observed on all the pins.This verified no damage on any of the pins by esd.The cause of this condition is unknown.No further relevant information has been received to date.

Event Description

Additional analysis was performed for the explanted generator.The premature end of life was determined due to a malfunction of the microcontroller (a1) causing persistent high current consumption that is still present when tested in product analysis.No other 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: 9663509
• MDR Text Key: 184257150
• Report Number: 1644487-2020-00171
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: 1000
• Device Lot Number: 204899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2019
• 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