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

Device Problem High impedance (1291)

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

Event Date 03/06/2014

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance (dc dc code - 7).It was reported that the device was programmed off after observing the high impedance.It was reported that there was no trauma that is believed to have caused or contributed to the high impedance.X-rays were sent to manufacturer for review.No discontinuities with the vns system were seen in the x-rays.It was unable to determine whether or not the lead pin was fully inserted into the generator header due to the orientation of the generator in the images.Attempts to obtain additional relevant information have been unsuccessful to date.No surgical intervention has been performed to date.

Event Description

An implant card was received indicating that the vns patent underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.The explanting facility discarded the explanted devices; therefore, no analysis can be performed.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

• 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: 3724441
• MDR Text Key: 4328024
• Report Number: 1644487-2014-00880
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 12 YR