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 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed.Review of manufacturing records confirmed that both the lead and the generator 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

It was reported that the patient铠vns system was tested on (b)(6) 2015 and system diagnostics returned a high impedance result with >=10000 ohms, current delivered=0.5ma, ifi=no.The programmed output current was reduced to 1ma and the pulse width was reduced to 250usec.It was reported that the patient was implanted with vns in (b)(6) 2011 and became seizure-free in (b)(6) 2011.It was reported that the cessation of seizures was thought to be a result of natural progression of the disease as opposed to the effect of vns.X-rays were taken and they were reported to be unremarkable by the healthcare professional.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.Review of manufacturing records confirmed that the lead and the generator passed all functional tests prior to distribution.No known surgical interventions have occurred to date.

Event Description

Further information was received indicating that the patient's epilepsy is well controlled without vns and that a surgical revision is not planned.X-rays of the patient dated on were reviewed by the manufacturer.The generator is placed in a normal position in the upper left chest.The filter feed-through wires appeared to be intact.The lead connector pin is fully inserted.The lead wires at the connector pin appeared to be intact.The electrodes at the vagus nerve implant site are not aligned, and the negative one appeared to be detached from the nerve.A strain relief loop was present, but not a bend.One tie-down was visible, securing the loop.Portions of the lead appeared to be behind the generator and could not be fully assessed.No acute angles, no breaks were found in the parts of the lead that could be assessed.

• 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: 4924659
• MDR Text Key: 22499553
• Report Number: 1644487-2015-05246
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2014
• Device Model Number: 302-20
• Device Lot Number: 2658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2010
• 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: 11 YR