MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 7304

Model Number 304-20

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

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the hemorrhage and tissue damage are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that at a new patient implant the surgeon mentioned that they had more blood loss than usual, 75 ml, and he said that when he was tunneling the bullet tip might have pulled on a vein or artery.The surgery was prolonged a bit in order to stop the bleeding.Information was received regarding the patient's reported hemorrhage, stating the "superficial vein was torn when tunneler was placed, during placement".It was stated that this event was probably related to vns surgery, no intervention was taken, and the patient has recovered.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 7304
• 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: 10257415
• MDR Text Key: 198320571
• Report Number: 1644487-2020-00928
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: Physician
• Type of Report: Initial
• Report Date: 07/10/2020

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
• Device Expiration Date: 01/05/2024
• Device Model Number: 304-20
• Device Lot Number: 205151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2020
• 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
• Patient Age: 57 YR