MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem Low impedance (2285)

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

Event Date 04/12/2016

Event Type  malfunction  

Event Description

Low impedance (=600 ohms) was observed for patient's device.In house programming history database contained programming history from date of implant, (b)(6) 2013 through (b)(6) 2015.The last diagnostics were performed on (b)(6) 2015, which showed normal impedance of 1092 ohms.On the day of initial implant, (b)(6) 2013, the impedance was 1118 ohms.Based on the diagnostic history, the device impedance value since implant has not exceeded 1200 ohms and were within normal limits.Patient was referred for a full revision surgery but no known surgical interventions have occurred to date.

Event Description

Patient underwent full revision surgery on (b)(6) 2016.The explanted devices have not been received to date.Additional information was received that the low impedance message was seen on (b)(6) 2016.It is unknown if there has been any change in patient's perception of stimulation since implant of the vns because the patient is non-verbal.

• Brand Name: LEAD MODEL 304
• 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: 5635666
• MDR Text Key: 45205957
• Report Number: 1644487-2016-00960
• 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
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Model Number: 304-20
• Device Lot Number: 202107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2012
• 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: 7 YR