MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 8103; GENERATOR

Model Number 8103

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

Patient Problem Depression (2361)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

It was reported that the study patient had adverse event of alcohol dependence, mild, with unknown relationship to vns therapy.Information was received that patient has worsening depression identified as mild with unknown relationship to vns.

Event Description

Information was received that action was taken (possible settings change).

Event Description

An update was received that no action was taken for this patient's event.Treatment was not changed and no change in medication.

Event Description

It was determined that the alcohol dependence and worsening depression are no longer considered a reportable event.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 8103
• 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: 13004597
• MDR Text Key: 283687676
• Report Number: 1644487-2021-01748
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2023

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: 09/30/2022
• Device Model Number: 8103
• Device Lot Number: 205433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 08/10/2022; 09/07/2022; 09/06/2023
• Supplement Dates FDA Received: 09/01/2022; 09/26/2022; 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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 Age: 51 YR
• Patient Sex: Male