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

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 10/16/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 7).The patient device was not disabled as the patient did not complaint of any discomfort.The patient was referred for surgery but no known surgical interventions have occurred to date.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

Event Description

It was also reported that the patient is anxious about not having vns as it has helped her in the past.

Event Description

The patient underwent a full replacement on (b)(6) 2016 due to battery depletion, unable to interrogate due to battery depletion and lead discontinuity.The generator and lead were received for analysis on 06/13/2016.Product analysis for the generator was completed and approved on 06/22/2016.An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the device was operating at a low battery condition (depleted).Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition.With the exception of the parameters that are associated with a low battery condition, the device performed according to functional specifications.Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no abnormal performance or any other type of adverse condition was found with the generator.

Event Description

Product analysis on the lead was completed and approved on 07/01/2016.A small 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 product analysis abraded openings were found on the inner tubing.Abrasions were observed in various locations, possibly caused by wear.Connector pin and connector ring coil breaks were observed with abraded openings on the inner tubes.Pitting was observed on the coil surface.Scanning electron microscopy was performed on the connector end of the connector ring quadfilar coil break (found at 356mm) and identified the area as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type with pitting on three of the broken coil strands.Pitting and residual material were 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.No other obvious anomalies were noted.

• 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: 4251020
• MDR Text Key: 4991247
• Report Number: 1644487-2014-03028
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2009
• Device Model Number: 302-20
• Device Lot Number: 1651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/14/2016; 06/27/2016; 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2006
• 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: 27 YR