MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Energy Output Problem (1431); Inappropriate or Unexpected Reset (2959)

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

Event Date 11/23/2020

Event Type  malfunction  

Event Description

It was reported via clinic notes that the patient's settings were disabled for an unknown reason.The programming history data for the device was analyzed and though no instances of the burst watchdog error were seen, based on report of the burst watchdog error being seen on the tablet, and evidence of the patient's autostimulation mode output current and magnet mode output currents were set equal to each other, it is likely that a burst watchdog disablement occurred.After re-programming the device so that the autostim output current was less than the magnet output current, it was confirmed within the programming history that the vns therapy was re-enabled.However, burst watchdog disablement cannot ultimately be confirmed since there was no error code reported to be seen upon interrogation of the patient initially when disablement was identified.The burst watch dog timeout is a known issue occurs when a rare combination of circumstances are present, one of which is when the autostim output current is programmed greater or equal to the magnet output current.No additional relevant information has been received to date.

Event Description

The programming history data for the device was analyzed and confirmed that a burst watchdog disablement had occurred.Due to unintended behavior in the model 106 aspire sr generator software, the generator can stop delivering stimulation unexpectedly.This event can only occur when a rare combination of circumstances are present, one of which is when the autostim output current is programmed greater or equal to the magnet output current.In this case the autostim output current mode was programmed equal to the magnet output current.Once the autostim output current was decreased to an output current less than the magnet mode output current, the vns pulse therapy was enabled.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11019892
• MDR Text Key: 222536114
• Report Number: 1644487-2020-01689
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2017
• Device Model Number: 106
• Device Lot Number: 203600
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR