MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

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

Event Type  malfunction  

Event Description

It was reported the patient needed to be scheduled for a full vns revision due to high impedance.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported the patient underwent full revision surgery on (b)(6) 2016.It was noted the patient had to be implanted on the right side as there was too much scar tissue and too many electrodes and anchor tethers on the left vagus nerve and there was no more room for an additional implant.It was noted the generator was replaced due to neos = yes (near end of service) and that the lead was replaced due to the high impedance observed.After the new generator and lead were replaced, the diagnostics were confirmed as ok.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was received noting the devices were discarded after surgery.Therefore, the devices are not expected for return and no analysis will be performed.

• Brand Name: LEAD MODEL 302
• 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: 5857766
• MDR Text Key: 52061719
• Report Number: 1644487-2016-01787
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• 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: 2478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2009
• 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