MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem No Information (3190)

Event Date 01/03/2015

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance (6592 ohms).Previous device diagnostics on (b)(6) 2015 were within normal limits (2736 ohms).X-rays were taken and did not identify any obvious discontinuities with the vns system.The generator was programmed off and the patient was referred to surgeon.No known surgical interventions have occurred to date.

Manufacturer Narrative

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

Event Description

Additional information was received that the patient is undergoing ent procedures to treat painful stimulation in the neck and head, voice alteration, and coughing that he has been experiencing since early january.However, the device being disabled has also helped diminish these symptoms as they were thought to be related to stimulation during high impedance.No known vns surgical interventions have occurred to date.

Manufacturer Narrative

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

Event Description

Additional information was received that the patient underwent a recent brain surgery and the vns is still disabled.The patient's previous neurologist has no additional information to provide.No known surgical interventions have occurred to date.

• Brand Name: LEAD MODEL 304
• 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: 4516986
• MDR Text Key: 5443842
• Report Number: 1644487-2015-03836
• 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,Followup
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/21/2014
• Device Model Number: 304-20
• Device Lot Number: 201584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 02/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/08/2015; 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2010
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR