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

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Convulsion, Clonic (2222)

Event Date 12/03/2021

Event Type  Injury  

Event Description

Patient reported experiencing an increase in seizures recently and is wanting to have her battery replaced asap.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient underwent generator replacement surgery.The explanted generator has not been received by product analysis to date.

Event Description

The explanted generator was received but product analysis is still underway.

Event Description

Product analysis was completed on the returned generator.The electrical tests performed in the pa lab found that the generator was at an neos = yes condition.The battery voltage was measured at 2.321 volts, and the memory locations on the generator indicated that 109.122% of the battery had been consumed.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.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator, due to the pulse generator remaining ¿on¿ post explant.Review of the ram/flash data downloaded from the pulse generator shows an indication of post explant increased impedance; the ¿diagvinitialprechange¿ value of 1916 ohms, the ¿diagvinitialpostchange¿ value of 13297 ohms, and the time of change detection 01/11/2022 (explant date ((b)(6)2022).Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no anomalies exist, and the near-end-of-service (neos) condition is an expected event.Other than the noted event (pulsedisabled ¿vboost¿ compliance voltage), there were no additional performance, or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

B5 describe event or problem, corrected data: supplemental report #02 report inadvertently left out relevant information h3 device evaluated by mfr?, corrected data: supplemental report #02 report inadvertently marked 'no' instead of 'yes' h6 adverse event problem codes, corrected data: supplemental report #02 report inadvertently left blank.

• Brand Name: PULSE GEN MODEL 106
• 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: 13118347
• MDR Text Key: 282967358
• Report Number: 1644487-2021-01849
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/10/2017
• Device Model Number: 106
• Device Lot Number: 4397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/10/2022; 03/16/2022; 05/04/2022
• Supplement Dates FDA Received: 02/04/2022; 04/08/2022; 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• 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 Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female