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

Model Number 302-20

Device Problem Fracture (1260)

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

Event Date 05/12/2017

Event Type  malfunction  

Event Description

It was reported that after the surgeon reviewed the patient's x-rays, he believed that the patient's lead was fractured.The patient's generator was completely depleted.Company representatives reviewed x-ray photos of a small area around the electrodes in the neck.The generator and the majority of the lead were not visible in the photos of the x-rays and so these portions could not be assessed.It was determined that there was a likely a large fracture of the lead in the neck after the patient's second tie-down.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

It was reported that the patient underwent revision of their generator and lead due to battery depletion and high impedance.The suspect generator and lead were discarded.No further relevant information was received to date.

Event Description

Per the manufacturer's battery life calculator, battery depletion was not expected at time of surgery.High impedance is known to accelerate battery depletion.No further relevant 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: 6616134
• MDR Text Key: 76825669
• Report Number: 1644487-2017-03934
• 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,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2009
• Device Model Number: 302-20
• Device Lot Number: 200354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2008
• 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: 18 YR