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

Model Number 106

Device Problem Energy Output Problem (1431)

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

Event Date 05/08/2019

Event Type  malfunction  

Event Description

It was reported in clinic notes that the patient's device was interrogated on (b)(6) 2019 and output currents were disabled.It was noted that "it appears there was something that caused the settings to be not 'compatible' and hence reset to 0".The settings were reprogrammed to what they should have been at.Information was received that the np may have changed the settings previously and the physician was not aware, but this is not confirmed.No other relevant information has been received to date.

Manufacturer Narrative

Corrected data, initial report: inadvertently did not include recent full settings and diagnostics.

Event Description

The patient's generator was replaced prophylactically.The explanted generator has not been received for analysis to date.No other relevant information has been received to date.

Event Description

The explanted generator was received for analysis.Product analysis has not been completed to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the generator.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.Results showed no signs of variation in the pulse generator¿s output signal.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.During the entire analysis process of the pulse generator, through the pa lab, the programmed settings maintained as programmed.There were no performance, or any other type of adverse conditions found with the pulse generator.No further 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: 10976836
• MDR Text Key: 220475860
• Report Number: 1644487-2020-01652
• 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,Followup,Followup,Followup
• Report Date: 05/27/2021

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: 03/22/2018
• Device Model Number: 106
• Device Lot Number: 4814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Event Location: Other
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/30/2020; 01/05/2021; 03/30/2021; 05/06/2021
• Supplement Dates FDA Received: 12/30/2020; 01/28/2021; 04/23/2021; 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR