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

Model Number 1000

Device Problem Output below Specifications (3004)

Patient Problems Depression (2361); Suicidal Ideation (4429); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

Event Description

It was reported that during generator replacement surgery, the new generator was being programmed to the patient's previous settings and a low output current error was seen.The pulse width was then lowered from 750 usec to 500 usec, and no further low output current messages were seen.No additional relevant information has been received to date.

Event Description

Additional information was received indicating that the patient has been referred for generator replacement.It was noted that the patient has had an increase in depression and suicidal ideations despite the patient's high vns settings.Generator data download was decoded and reviewed.Based on the data received, it appears that the lower output current delivered was related to the high programmed settings, including the high pulse width and high duty cycle.No known relevant surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

The patient underwent vns generator replacement due to battery depletion.The explanted generator has not been received by the manufacturer to date.No additional relevant information has been received to date.

Event Description

The suspect device was received by the manufacturer and product analysis (pa) was completed.The reported ¿suicidal ideation¿ and ¿increased depression¿ is outside of the scope of the pa lab.The reported ¿output current low¿ was not duplicated in the pa lab.Comprehensive electrical testing showed that the generator performed according to all specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.

• 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: 11575496
• MDR Text Key: 245926312
• Report Number: 1644487-2021-00423
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/12/2022
• Device Model Number: 1000
• Device Lot Number: 6778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 09/27/2021; 11/29/2021; 01/27/2022
• Supplement Dates FDA Received: 10/22/2021; 12/23/2021; 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• 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): Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Male