MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 300

Model Number 300-30

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384)

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

Event Date 06/01/2015

Event Type  malfunction  

Event Description

The patient's vns was returned to the manufacturer for an unknown reason.Follow-up with the physician's office showed the patient was explanted due to a lack of efficacy and because she wanted to be able to have mris.A battery life calculation was performed which showed the no anomalies and indicated the patient would have approximately 4.3 years remaining until the neos = yes (near end of service) condition.The information available was only from (b)(6) 2011 through (b)(6) 2012.The programming history database was reviewed which showed no anomalies.The information available was from (b)(6) 2011 through (b)(6) 2012.Product analysis for the returned lead was completed.During analysis, a coil break was observed, along with abrasions on the inner and outer silicone tubes.Scanning electron microscopy (sem) was performed which identified the area as having extensive pitting which prevented the identification of the fracture type.Sem was then performed on the mating end of the broken coil and identified the area on three of the broken strands as being mechanically damaged with fine pitting which prevented the identification of the fracture type.The area of the remaining broken strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting.Flat spots and pitting were observed on the coil¿s surface.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Low magnification sem analysis of the coil shows characteristics typical of a lead discontinuity, which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching, or material dissolution.Additional follow-up with the physician's office showed that the patient was seen for a visit in (b)(6) 2015 and the device showed high impedance with a dcdc value of 7, which had increased from a previous value of 1.It was noted the patient's previous visit was in september of 2014 and the high impedance was believed to have occurred sometime between those dates.It was noted the patient's seizures had decreased after lacosamide was started and after the high impedance was first observed, indicating the patient did not benefit from the vns.

• Brand Name: LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6305667
• MDR Text Key: 66660859
• Report Number: 1644487-2017-03143
• 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
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/13/2003
• Device Model Number: 300-30
• Device Lot Number: 4308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 42 YR