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

Model Number 302-20

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

Patient Problems Neck Pain (2433); No Code Available (3191)

Event Date 01/05/2017

Event Type  malfunction  

Event Description

It was reported that the patient presented to the physician's office because she had been experiencing painful stimulation at the electrode site and coughing for the previous two weeks.During the visit a diagnostic test was performed which resulted in high impedance.The device was then programmed off.The patient reported no recent trauma or manipulation to the device that could have contributed to the high impedance.X-rays were performed and the physician stated that the lead appeared smooth and no kinks were observed.These x-rays have not been reviewed by the manufacturer to date.The patient was then referred for a lead and generator replacement however no surgical interventions are known to have occurred to date.No additional relevant information has been received to date.

Event Description

The patient underwent surgery to address the high impedance.The surgeon attempted to reinsert the lead pin however the high impedance did not resolve.The generator was then removed from the lead and tested with a test resistor.The results showed the generator was functioning normally on its own.Therefore it appeared that the cause of high impedance was likely a lead fracture.The lead and generator were then replaced.The explanting facility historically does not return explanted product.Therefore product analysis is not expected to be completed.

• 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: 6327184
• MDR Text Key: 67298284
• Report Number: 1644487-2017-03197
• 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: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2005
• Device Model Number: 302-20
• Device Lot Number: 009541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2003
• 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: 48 YR