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

Model Number 7103

Device Problems Inappropriate or Unexpected Reset (2959); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 08/05/2021

Event Type  malfunction  

Event Description

During a routine follow-up appointment upon interrogating the patient's device, an error message was received which resulted in the patient's device being disabled.The error messages stated, "the pulse generator is currently disabled due to a wand reset.Note that the generator is not supplying stimulation." programming history was reviewed and a hardware reset was noted on (b)(6) 2021 and (b)(6) 2021 after an initial interrogation was performed.Design history record review for the generator was performed.The generator passed final functional and quality specifications prior to release for distribution.No other relevant information has been received to date.

Event Description

Additional information received noting that the patient was seen and their output current was found to be at 0ma.An error message of "ipg is disabled and not supplying stimulation¿ was seen.Diagnostics were okay.

Event Description

Internal investigation revealed dendritic growth was observed on the routed edge of the printed circuit board assembly inside a returned affected generator.It is believed that conductive residues deposited on the edge of the circuit board during the laser-routing manufacturing process likely promoted an environment conducive for dendritic growth to occur between test points on the telemetry and reset circuits.The probable root cause is considered related to the laser-routing process (manufacturing error caused event).

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12385442
• MDR Text Key: 268730078
• Report Number: 1644487-2021-01223
• 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,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

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: 7103
• Device Lot Number: 6749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 12/21/2021; 05/26/2023
• Supplement Dates FDA Received: 01/14/2022; 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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: Male