MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 302

Model Number 302-20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Seizures (2063); Inadequate Pain Relief (2388)

Event Date 04/01/2016

Event Type  malfunction  

Event Description

It was reported that vns patient implanted in 2011 has reading >10000ohms on the system diagnostic test performed on the vns system.It was reported that patient's mother feels that the vns system may be inactive for a few months and patient seizure control has deteriorated over the past few months.It was reported that patient gets clusters of both simple and complex partial seizures and has not had a convulsion in a great period of time.Nurse reduced the vns system parameters to minimal settings as the current is not being delivered and has referred the patient for x- rays.Xrays were not provided to the manufacturer for review.Additional information was received that the patient was referred to surgeon; due to patient confidentiality, no further information could be disclosed.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 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: 5652807
• MDR Text Key: 46474912
• Report Number: 1644487-2016-01005
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2013
• Device Model Number: 302-20
• Device Lot Number: 201233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2009
• 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: 31 YR