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

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291)

Patient Problems No Known Impact Or Consequence To Patient (2692); Fibrosis (3167)

Event Date 12/30/2015

Event Type  malfunction  

Event Description

It was reported through clinic notes dated (b)(6) 2015 that the patient's vns system indicated a high lead impedance.Surgery to explant the lead has not occurred to date.No additional pertinent information has been received to date.

Event Description

It was reported that the patient's generator and lead were explanted.The explanting facility discards products per their protocols, so return and analysis of the explanted devices could not be performed.No additional pertinent information has been received to date.

Event Description

It was reported that the patient¿s nerve remained irritated due to the presence of fibrotic scar tissue.No medical intervention was noted for the fibrosis, but its relation to the high impedance has not been clarified to date.No additional pertinent information has been received to date.

Event Description

Communication with the explanting surgeon showed that fibrosis was observed around the lead coils at the time of explant.No assessment was given that described any potential contribution to the reported high impedance.No additional pertinent information has been received to date.

• 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: 5495034
• MDR Text Key: 40455080
• Report Number: 1644487-2016-00485
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2006
• Device Model Number: 302-20
• Device Lot Number: 011464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2004
• 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: 46 YR