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

Model Number 302-20

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260); Mechanical Problem (1384)

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

Event Date 10/01/2017

Event Type  malfunction  

Event Description

It was reported that during the patient¿s generator replacement surgery, their explanted generator could not be interrogated.When their generator was replaced, a system diagnostic test was performed and high impedance observed.The lead pin was removed and reinserted with a second result of high impedance.Therefore the lead was inspected, and the surgeon noticed a small tear in the lead.The lead was therefore explanted and a new lead was implanted.Additional information was received from the surgeon¿s office stating that the tear in the lead was present in the outer and inner tubing.The surgeon¿s believed cause of the reported tear in the lead was stated to be due to the patient falling 6 months prior when they sustained a left clavicle fracture.Lastly it was stated that the vns has been working poorly for those 6 months.The explanted products have not been received by the manufacturer to date.No other relevant information has been received to date.

Event Description

The lead and generator were received by the manufacturer for product analysis.The lead underwent product analysis and abraded openings were observed on the outer silicone tubing with a small abraded opening on one of the inner silicone tubes.Several fractures were observed in the returned portion of the lead.Scanning electron microscopy was performed which identified pitting and residual material on the fractured pieces.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.The abraded openings found on the inner and outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubing.The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.With the exception of the observed discontinuity and abraded tubing openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The generator underwent product analysis and the battery status was confirmed to be set at eos (end of service) = yes.With the exception of the end of service battery status setting, the device performed according to functional specifications.Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.No other 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: 7321919
• MDR Text Key: 101971627
• Report Number: 1644487-2018-00357
• 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
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2008
• 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: 34 YR