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

Model Number 304-20

Device Problem High impedance (1291)

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

Event Date 11/02/2015

Event Type  malfunction  

Event Description

A physician reported observing high lead impedance from a patient's vns system with no known falls or injuries.The physician disabled the device in response to the high impedance observation and the patient was referred for surgical consult.X-rays were taken and appeared to be normal.Programming and diagnostic data was submitted which confirmed the high impedance measurement.The internal device data from a programming session on (b)(6) 2015 showed that the last 25% change in impedance value was estimated to have occurred on (b)(6) 2015, where the impedance value changed from 13,574 ohms to 21,358 ohms.Normal battery status was observed on the pulse generator.No known surgical interventions have occurred to date.

Event Description

New information was received indicating that the providers intended to perform a full system revision for the patient as the providers wished to avoid the risk of infection by leaving the former pulse generator implanted when performing the lead revision.Subsequent information was received indicating that the patient underwent successful explant and replacement of her pulse generator and lead.Pre-operative device diagnostics indicated that the high impedance condition was still present.While explanting the former lead the surgeon observed that one of the wires had broken near the electrode area.The former lead was cut below the electrodes, leaving the electrodes on the nerve, and the electrodes of the new lead were placed above the electrodes of the former lead.Normal system diagnostics were observed with the new pulse generator and lead.The pulse generator and lead were returned to the manufacturer and are currently undergoing product analysis.

Event Description

Analysis of the returned lead portions showed that the outer silicone tubing had a compressed appearance at multiple locations and a cut opening at one location.A break was identified in both lead coils at approximately 0.3cm past the electrode bifurcation.Pitting was observed at the break locations.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.There were no performance or any other type of adverse conditions found with the pulse generator and a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Device memory indicates an indication of increased lead impedance on the date of explant ((b)(6) 2016) from 21,358 ohms to 14,236 ohms confirming the likely presence of a high impedance condition prior to explant.The battery, 2.984 volts as measured during testing, shows an ifi=no condition.

• 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: 5334388
• MDR Text Key: 35169533
• Report Number: 1644487-2015-06841
• 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,Followup,Followup
• Report Date: 12/10/2015

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: 11/30/2014
• Device Model Number: 304-20
• Device Lot Number: 201623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/15/2016; 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2010
• 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: 31 YR