MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

Device Problems Mechanical Problem (1384); Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2019

Event Type  malfunction  

Event Description

It was reported that a patient was involved with a burn unrelated to vns and needed to be operated on to treat the burn wounds.The company representative was called in to interrogate the vns and assist with surgery precautions as needed.Upon interrogating the device, a low impedance error message was received.It was noted that the patient's x-rays appeared fine, and that the patient's mother mentioned that the device had previously shown low impedance, and that the neurologist had been monitoring it.An update was received from after the surgery to treat the burn wound, located on the neck and chest.It was noted that the surgery involved bovie, a form of electrocautery.The surgeon was advised about use of electrocautery around the vns, but it was stated that the surgery could not be completed otherwise.Post-operatively, the device was turned back on and the impedance was noted to be >600ohms.No further relevant information was received to date.

Event Description

It was reported that due to the burns the patient sustained last year, a skin graft surgery took place.During this surgery, the surgeon accidentally nicked the lead.The device was then disabled without immediate revision of the lead.The patient is now experiencing an increase in seizures while the device is disabled, and so he was referred for a full revision.No known relevant surgical intervention has occurred to date.No additional information has been received to date.

Event Description

It was reported that the patient underwent full revision.Lead impedance was reported to be normal post-operatively.The explanted generator and part of the explanted lead were received for product analysis, which has not been completed and approved to date.No additional information has been received to date.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• 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: 8296859
• MDR Text Key: 134734623
• Report Number: 1644487-2019-00192
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/05/2012
• Device Model Number: 303-20
• Device Lot Number: 2266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2009
• 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 Age: 18 YR