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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Pain (1994)

Event Date 09/24/2014

Event Type  Malfunction  

Event Description

It was reported that the vns patient was sent for x-rays due to concerns with her device lead impedance. X-rays were taken and were reported by the physician to be unremarkable. Follow-up revealed that the patient¿s concerns with lead impedance were due to pain occurring with magnet mode stimulation on-times. The patient¿s magnet output current was subsequently reduced. Patient manipulation or trauma is not believed to have caused or contributed to the event. Follow-up revealed that the patient¿s device was tested and diagnostic results revealed high impedance (dc dc ¿ 6). X-rays dated (b)(6) 2013 and (b)(6) 2014 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 cannot be confirmed to be fully inserted into the generator connector block with the images provided. 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. Based on the images provided, the cause of the high lead impedance remains unknown. No known surgical interventions have occurred to date.

Event Description

Additional information was received stating that the high impedance was first observed (b)(6) 2014.

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.

• 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: 4230225
• MDR Text Key: 5073897
• Report Number: 1644487-2014-02946
• 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
• Reporter Occupation: HEALTH PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 10/07/2014

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 11/06/2014
• 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: 2689
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 05/24/2010
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial