MAUDE Adverse Event Report: LIVANOVA USA, INC. VITARIA GEN MODEL 7103; GENERATOR

Model Number 7103

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova & #39;s employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any & #34;defects¿ or & #34;malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

The patient recently underwent a lvad implantation and then had defibrillation/cardioversion performed and has since been experiencing a strong pain in their neck area.The patient's device was checked and the battery life was found to be at near end of service but when last interrogated on (b)(6) 2023 the device was at full battery.The patient will be undergoing a battery replacement and the explanted device will be returned for product analysis.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Internal data received from the generator and reviewed.Additional information received noting that the external defibrillation occurred on (b)(6) 2023 and it does not appear that the recommendations in the vitaria system physician¿s manual regarding "external defibrillation or cardioversion" were followed by the site.The patient's device was disabled and remains implanted.The device history records were reviewed for the generator.The generator passed final functional and quality specifications prior to release for distribution.

Event Description

Additional information received noting that the patient underwent surgery to have their generator explanted.The explanted generator has not been received by product analysis to date.

Event Description

Additional information received noting that the lvad system was placed on (b)(6) 2023 and the patient will undergo explant surgery.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The suspect device was received but product analysis is still underway.

• Brand Name: VITARIA GEN MODEL 7103
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18066004
• MDR Text Key: 327293352
• Report Number: 1644487-2023-01589
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2024

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: 07/16/2022
• Device Model Number: 7103
• Device Lot Number: 205352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 12/14/2023; 01/15/2024; Not provided
• Supplement Dates FDA Received: 01/08/2024; 02/09/2024; 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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 Sex: Female