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

Model Number 302-20

Device Problems High impedance (1291); Device Inoperable (1663)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

It was reported by the nurse that the vns patient could not feel stimulation from the vns device.Diagnostic testing performed during the office visit revealed high impedance (lead impedance >= 10,000 ohms).The patient did not report any manipulation or trauma which may have caused or contributed to the high impedance.The patient underwent replacement surgery on (b)(6) 2014.The x-rays were sent to the manufacturer where analysis is currently underway.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Review of the x-rays was completed on (b)(6) 2014 and was inadvertently left off of initial mfr.Report.Review of the x-ray was unable to determine if the lead pin is fully inserted.There do not appear to be any gross fracture, discontinuities, or sharp angles.The cause of the high impedance could not be determine; however, the presence of a micro-fracture in the lead cannot be ruled out.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by the manufacturer, no gross lead discontinuities.

Event Description

Information obtained indicates that the explanted devices were discarded and are not available to be returned for product analysis.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3679933
• MDR Text Key: 4244419
• Report Number: 1644487-2014-00692
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2007
• 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: 41 YR