MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260)

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

Event Date 11/10/2017

Event Type  malfunction  

Event Description

It was reported that the patient wanted to get her vns removed.She stated that she doesn¿t think it¿s working anymore.She says it worked and helped her in the beginning, but stopped working for her later on and has been that way for a while.Information was received that the patient¿s device was fully explanted.The explanted generator and lead were received for analysis.Product analysis for the generator was completed and approved.During the analysis, there was no indication from the device that an end of service condition existed.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The device performed according to functional specifications.Product analysis on the lead was completed and approved.During the visual analysis of the returned 42mm portion quadfilar coil 1 appeared to be broken approximately 9mm from the end of the cut outer / inner silicone tubes.Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type.The area on the remaining broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type.Pitting and residual material was observed on the coil 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 quadfilar 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.The abraded opening found on the 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 silicone tubing.No other obvious anomalies were noted.Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity with the returned portions of the device.Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No additional information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 8125705
• MDR Text Key: 129082321
• Report Number: 1644487-2018-02194
• Device Sequence Number: 1
• Product Code: MUZ
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/22/2009
• Device Model Number: 302-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Event Location: Other
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2006
• 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: 55 YR