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

Model Number 7103

Device Problems High impedance (1291); Incomplete or Inadequate Connection (4037)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

It was reported that the patient had high impedance 10,000 ohms on diagnostic testing during implantation.Connection between the lead and the generator was checked, as well as the placement of the lead on the nerve.The lead and the generator were reconnected but same problem still existed.After using test resistor, value of impedance was in allowed range.The lead was then replaced and implantation was successfully completed.Device history record for the lead was reviewed and showed that the lead passed all specifications with no non-conformances prior to distribution.The lead has not been received for analysis to date.No additional relevant information has been received to date.

Event Description

Explanted lead was received for product analysis, though analysis has not been completed to date.No other relevant information has been received to date.

Event Description

Product analysis was performed for the patients lead.Continuity checks of the returned lead assembly were performed during the functional analysis, and no discontinuities were identified.Three half sets of setscrew marks were found near the end tip of the connector pin, suggesting that the lead connector was not inserted completely at least at one point in time, meaning incomplete pin insertion was likely the cause for the high impedance.The lead connector was inserted completely in the header of a representative pulse generator and no anomalies that prevented proper insertion were identified.The condition of the returned lead assembly is consistent with conditions that typically exist following an implant/explant procedure.No other relevant information has been received to date.

• 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: 14269871
• MDR Text Key: 290777467
• Report Number: 1644487-2022-00508
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2023

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: Health Professional
• Device Expiration Date: 07/16/2022
• Device Model Number: 7103
• Device Lot Number: 205381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 05/03/2022
• Supplement Dates Manufacturer Received: 06/05/2023; 07/19/2023
• Supplement Dates FDA Received: 06/30/2023; 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2018
• 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