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

Model Number 7103

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2019

Event Type  malfunction  

Event Description

It was reported that during a patient implant case the surgeon could not put the lead completely inside the header block of the generator.It was noted that the hexscrew was completely backed out of the generator, and that a small white silicone like substance was seen around the metal part of the hexscrew.Therefore, the generator was replaced with another one for implant, and it was reported that there were no problems with the new generator.It was mentioned that pin re-insertion was attempted several times by the surgeon.After several attempts, the silicone insulate of the screw stuck on the screw driver.A review of device history records for the generator shows that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.The generator has not been received to date.No other relevant information has been received to date.

Event Description

The generator was explanted and returned due to ¿product opened but not used¿ due to a reported allegation of a ¿device failure¿.The reported device failure was not duplicated in the product analysis laboratory.Per the initial report, the hexscrew was completely backed out of the generator, and a small white silicone like substance was seen around the metal part of the hexscrew.Therefore, the generator was replaced with another one for implant a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The reported detachment of the septum plug was observed with the generator¿s ¿as received¿ condition prior to decontamination.The returned septum meets specification requirements and the pulse generator header septum cavity meets specification requirements.The returned setscrew shows mechanical wear at the socket, which suggests numerous insertion attempts; however, the socket is not stripped and the returned torque wrench fully inserted with no issues.In addition, the returned septum shows damage on the underneath side, which suggest the setscrew was extracted up into the septum, which may have been the contributing factor for the detachment of the component.Additionally, the reported allegation of lead ¿insertion difficulties¿ was not duplicated in the product analysis laboratory.Was not duplicated in the product analysis lab.The in-line cavity go gauge test, designed to verify proper lead cavity dimensions in the header area, passed.A bench lead fully inserted into the pulse generator header, past the negative connector block.There were no performance or any other type of adverse conditions found with the pulse generator.No other relevant information has been received to date.

Event Description

The generator was received by the manufacturer.Analysis is underway but has not been completed to date.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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8620591
• MDR Text Key: 145415602
• Report Number: 1644487-2019-00957
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2019

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: 07/10/2020
• Device Model Number: 7103
• Device Lot Number: 204594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 05/20/2019; 07/01/2019
• Supplement Dates FDA Received: 06/12/2019; 07/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2018
• 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