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 10/15/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device showed a high impedance condition (impedance value >= 10,000 ohms).Diagnostic results for the past year showed normal device function.X-rays were taken and reported to show the lead being ¿angulated.¿ x-rays were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.The patient was referred for surgery but no known surgical interventions have occurred to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Additional information was received stating that the vns patient¿s device first showed a high impedance condition during an office visit on (b)(6) 2015.The patient¿s device was subsequently disabled.

Event Description

It was reported the patient was re-implanted with a new vns on (b)(6) 2016; however, this was later confirmed invalid by the physician who noted the patient was re-implanted on (b)(6) 2016.The surgery was a full revision and the patient received a new lead and vns generator.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The explanted lead and generator were received by the manufacturer for analysis.The lead analysis was completed and a lead break was confirmed as a coil break was identified on what was believed to be the negative coil.Scanning electron microscopy images of the negative coil broken ends show that pitting or electro-etching conditions have occurred at the break locations.Due to pitting, mechanical distortion (smoothed surfaces), and/or surface contamination, the fracture mechanism of the coil could not be ascertained.Generator analysis is expected but has not been completed to date.

Event Description

Product analysis for the returned generator was completed.The review of the ram/flash data downloaded from the generator shows an indication of increased impedance from 5267 ohms to 10,013 ohms, and the date of change detection of (b)(6) 2014 (explant date (b)(6) 2016).The vns programming history database shows the last known diagnostic test was performed on (b)(6) 2013 with an impedance value of 2133 ohms (implant date (b)(6) 2012).Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications.The batter voltage indicated an ifi = no condition.There were no performance or any other type of adverse conditions found with the generator.

• 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: 4554478
• MDR Text Key: 5478630
• Report Number: 1644487-2015-04002
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2008
• Device Model Number: 302-20
• Device Lot Number: 945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2005
• 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: 21 YR