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

Model Number 302-20

Device Problem Material Frayed (1262)

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

Event Date 08/17/2015

Event Type  malfunction  

Event Description

During the planned generator replacement surgery, the surgeon observed that the lead appeared to be frayed and "shredded." it was reported that there was no indication of high lead impedance.As a result, the lead was also replaced.It was unknown if the leads were intact and it was just an issue with the insulation.The explanted lead has been received for analysis by the manufacturer.However, analysis has not been completed to date.The return product form indicated the reason for lead replacement as "lead discontinuity.".

Event Description

Analysis was completed on the explanted generator and lead.Note that a large portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During visual analysis, there were two areas of the quadfilar coils that appeared to be broken.Scanning electron microscopy (sem) identified the areas as having evidence of being worn to the point of fracture with flat spots on the coil surfaces and no pitting.An abraded opening was observed on the outer silicone tubing with body fluids inside the tubing.It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces.The abraded opening was found on the outer and inner silicone tubing, which most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubing.The lead assembly has dried remnants of what appear to have once been body fluids inside the outer and inner silicone tubes, in some areas.No other obvious anomalies were noted.There was no additional anomalies observed except for damage made during the explant process.Analysis of the generator confirmed no anomalies with the device.Review of device manufacturing records of the generator and lead confirmed that all quality tests were passed prior to distribution.

• 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: 5060259
• MDR Text Key: 25881154
• Report Number: 1644487-2015-05714
• 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: Health Professional
• Type of Report: Initial
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2005
• Device Model Number: 302-20
• Device Lot Number: 8350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2005
• 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: 20 YR