MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 303

Model Number 303-20

Device Problem Fracture (1260)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient stomach was twitching which was suspected to a suspected lead fracture.The patient's device was subsequently disabled.However, the patient's device was tested and showed lead impedance within normal limits (impedance value - 2500 ohms).Additionally, x-rays were provided to the manufacturer for review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Additional information was received stating that the patient's device had been programmed back on to evaluate stimulation on-times by evoked potential monitoring.The recording were provided to the manufacturer for review.Based on the recordings, the patient's lead was suspected to be fractured as it appeared device stimulation was not being delivered.The patient's device was again disabled.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.No known surgical interventions have occurred to date.

• Brand Name: LEAD MODEL 303
• 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: 5225087
• MDR Text Key: 31610573
• Report Number: 1644487-2015-06404
• 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: Other
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2017
• Device Model Number: 303-20
• Device Lot Number: 3613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2013
• 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: 9 YR