MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

Model Number 300-20

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/31/2014

Event Type  Injury  

Event Description

Hospital procedure notes dated (b)(6) 2014 note that during generator and lead replacement surgery (mfr.Report # 1644487-2014-03136), during dissection of the electrodes from the patient's vagus nerve the surgeon experienced brisk venous bleeding from the jugular vein.The surgeon identified a small hole in the vein and controlled the bleeding with direct pressure and then closed the hole with a 5-0 prolen interrupted suture.The surgeon then placed surgicel over this.It was noted that the patient tolerated the procedure well and was transferred to pacu in stable condition.The physician assistant indicated that the bleeding is a known complication when removing old lead and that the risk was discussed prior to surgery.It was reported that the vns caused this in the fact of it's presence and the leads scared down to the surrounding anatomy.

Manufacturer Narrative

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS INC; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS INC; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 4476773
• MDR Text Key: 5499294
• Report Number: 1644487-2015-03737
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2003
• Device Model Number: 300-20
• Device Lot Number: 4309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2001
• 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; Required Intervention
• Patient Age: 36 YR