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

Model Number 7103

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

Patient Problem Tissue Damage (2104)

Event Date 05/14/2019

Event Type  Injury  

Event Description

It was reported that during the vns implant procedure, the patient acquired burns on the skin surface of the neck and back in the operating room.The burns were caused during the implant surgery but were reportedly not directly related to the generator or leads or their placement.The surgeon indicated that the burns were related to the use of electrocautery and that the neutral electrode of the electrocautery was connected to the skin and the skin was wet.The surgeon reported that the burns were mild and "will heal quickly." no further 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: 8694242
• MDR Text Key: 147846144
• Report Number: 1644487-2019-01132
• 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
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/17/2020
• Device Model Number: 7103
• Device Lot Number: 204563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/12/2019
• Date Device Manufactured: 07/27/2018
• 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
• Patient Outcome(s): Other