MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL UNKNOWN; GENERATOR

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

Patient Problem Tissue Damage (2104)

Event Date 09/24/2019

Event Type  Injury  

Event Description

The patient sustained a thoracic duct injury indicated to probably related to the vns implant procedure.The patient was provided medication and underwent surgical ligation of the lymphatic channel and drainage of the fluid with bulb suction.No other relevant information has been received to date.

Event Description

During surgery the neurosurgeon noted that the vagus nerve appeared to be aberrantly located at the anterior aspect of the carotid sheath.To ensure the visualized nerve was the vagus nerve the surgeon performed an exploratory dissection.This dissection was not posterior to the internal jugular vein or posterior to the carotid sheath.During the dissection, milky fluid was noted coming out of the site.An ent was consulted and it was determined the fluid was caused by a lymphatic leak.The wound was irrigated and the sternocleidomastoid muscle was retracted laterally.The fluid was visualized and appeared to contain fat.Fibrofatty tissue and lymph node tissue were identified and grasped.The leak was then stopped with clips and silk sutures.After multiple irrigations the extensive drainage was noted to have subsided.The wound was irrigated and a drain for bulb suction was placed in the subplatysmal space and tunneled to an exit site laterally and sutured.The wound was then closed.The neurosurgeon and ent noted that the patient's anatomy was unusual due to the location of lymphatic channels within the carotid sheath between the internal jugular vein and the carotid artery.Due to the increased risk of wound complications from lymphatic leak, it was determined a vns system would not be placed.

• Brand Name: PULSE GEN MODEL UNKNOWN
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10252785
• MDR Text Key: 198173639
• Report Number: 1644487-2020-00926
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR