MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

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

Patient Problem Tissue Damage (2104)

Event Date 08/25/2020

Event Type  Injury  

Event Description

It was reported that the patient had a recent generator replacement.During surgery, the patient required vascular repair.The patient was admitted overnight and give blood thinners to address clotting.At the patient follow up appointment, the patient was noted to be experiencing dysphagia.The physician believes it is due to extra healing strain from the vascular repair.The patient was reported to not have had swallowing issue with the previous device.The report of blood thinners prescribed to address clotting can be associated as a preventative measure to reduce clotting, which could occur due to vascular surgery.Any clotting that could have occurred would have been due to the vascular damage, which was caused by the surgical error.It was stated that the vascular damage occurred while the existing lead was being taken off due to the lead fracture.The surgeon was snipping tissue in the area of lead and a small vascular branch coming off the jugular vein was snipped causing the tissue damage.A vascular surgeon was brought in to assist the neurosurgeon as they could not repair on their own.The neurosurgeon stated they were not aware that snipping the tissue surrounding the lead would cause the vascular damage.It was stated by the sales representative that the surgeon did take responsibility for the vascular repair required and that the event was caused only due to surgical error.It was noted that the sales representative was at the appointment with the patient when the dysphagia was observed and the epileptologist believed further healing was needed due to the vascular damage.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 10554793
• MDR Text Key: 207572339
• Report Number: 1644487-2020-01241
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2023
• Device Model Number: 304-20
• Device Lot Number: 6497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 21 YR