MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

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

Patient Problem Seizures (2063)

Event Date 01/18/2017

Event Type  malfunction  

Event Description

It was reported that the patient had not been feeling vns stimulation since a recent generator replacement.Diagnostics were performed at an office visit which resulted in a low impedance warning.The patient confirmed that he did not fall or hit the generator since the surgery.X-rays were performed and reviewed by the physician who stated that the lead pin was fully inserted.These x-rays have not been reviewed by the manufacturer to date.The generator was not programmed off after the low impedance warning was observed.It was later reported that the patient was experiencing an increase in seizures since the low impedance had been observed.The patient was then referred for replacement surgery.It was unclear if the surgery would just be a lead replacement or a lead and generator replacement.No surgical interventions are known to have occurred to date.

Event Description

The patient underwent a lead and generator replacement due to the low impedance.The explanted lead and generator were received by the manufacturer and they are both currently pending analysis.Further follow-up with the physician clarified that the increase in seizures was below pre-vns baseline.

Event Description

Product analysis on the generator found that the device performed to functional specification.Magnet activations were successfully performed and the device provided the programmed settings.Analysis on the lead found that there was abraded insulation in the inner tubing which potentially allowed for a short circuit condition to occur.

• 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: 6339315
• MDR Text Key: 67722764
• Report Number: 1644487-2017-03222
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2003
• Device Model Number: 300-20
• Device Lot Number: 4399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2001
• 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): Required Intervention
• Patient Age: 43 YR