MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260); High impedance (1291)

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

Event Date 01/25/2017

Event Type  malfunction  

Event Description

It was reported that the patient¿s vns system registered high lead impedance.There was no suspected trauma to the area of the vns.Follow up with the neurology office showed that the patient was being referred for surgery, but surgery had not occurred to date.The device was confirmed to have been disabled after the high impedance was encountered.The generator and lead device history records were reviewed, and it was found that all specifications were met prior to distribution.No additional pertinent information has been received to date.

Event Description

The patient¿s implant card from the preceding implant surgery was reviewed.It was found that impedance was within normal limits at the time of completion of surgery.No additional pertinent information has been received to date.

Event Description

It was reported that the patient¿s lead was replaced in surgery.When the surgeon opened up the patient¿s generator pocket, the lead was observed to have an obvious lead break about 6 inches from the connector pin.Based on the appearance of the lead, the surgeon expressed the patient likely excessively manipulated the lead.The suspect lead was received by the manufacturer and is undergoing product analysis.No additional pertinent information has been received to date.

Event Description

Product analysis was completed on the returned lead portion.Note that the electrodes were not returned for analysis.Therefore, a complete evaluation could not be performed on the entire lead.During the visual analysis, the ends of both the connector pin and connector ring quadfilar coils appeared to be broken approximately 8mm from the electrode bifurcation.Scanning electron microscopy (sem) was performed on the connector pin coil break and identified the area as having evidence of electro-etching and residual material.Sem was performed on the connector ring coil break and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage and residual material.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 quadfilar coil shows characteristics typical of a lead discontinuity.An abraded opening found on the outer silicone tubing likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.With the exception of the above observations, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that a good mechanical and electrical connection was present at one point in time.Continuity checks of the returned lead portion were performed and no other discontinuities were identified.

• Brand Name: LEAD MODEL 304
• 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: 6339143
• MDR Text Key: 67722558
• Report Number: 1644487-2017-03220
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/24/2020
• Device Model Number: 304-20
• Device Lot Number: 203771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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: 62 YR