MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem High impedance (1291)

Patient Problem Discomfort (2330)

Event Date 03/20/2015

Event Type  malfunction  

Event Description

The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015.Pre-operative diagnostic results showed a high impedance condition (impedance value >= 10,000 ohms).The explanted devices have not been returned to date.

Event Description

It was reported that device diagnostics resulted in high impedance (>10,000 ohms).X-rays were taken and device settings were increased.It was reported that the patient would be referred for surgery and x-rays would be sent to manufacturer for review.It was later reported that the increased settings caused the patient to have a "chewing on foil" sensation when turning his head.The device was later disabled.X-rays were received by manufacturer to review.Review of x-rays did not identify any obvious discontinuities with the vns system; however, a micro-fracture could not be ruled out.It was reported that the patient plans on undergoing oral surgery prior to vns system replacement.No known surgical interventions have occurred to date.

Manufacturer Narrative

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

• Brand Name: BIPOL LEAD MODEL 300
• 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: 4698547
• MDR Text Key: 17302979
• Report Number: 1644487-2015-04476
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2003
• Device Model Number: 300-20
• Device Lot Number: 2468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2001
• 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: 43 YR