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

Model Number 304-20

Device Problems High impedance (1291); Output Problem (3005)

Patient Problems Itching Sensation (1943); Undesired Nerve Stimulation (1980)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that low output current and high impedance was identified during interrogation of a patient.The patient's settings were adjusted, which temporarily resolved the low output current, but the high impedance was still present.X-rays were taken, but the cause of the high impedance could not be identified.The patient also reported feeling mildly painful stimulation one time at the generator site and itching at the neck during interrogation.The patient's device was programmed off until the cause of the high impedance, itching, and pain could be identified and fixed.Surgery to determine the cause of the high impedance is expected, but has not occurred to date.

Manufacturer Narrative

Brand name, corrected data: initial report inadvertently listed the wrong brand name of the suspect device.Model #, serial #, lot #, expiration date, corrected data: initial report inadvertently listed the wrong model, serial number, lot number, and expiration date of the suspect device.Manufacture date, corrected data: initial report inadvertently listed the wrong manufacture date of the suspect device.

• Brand Name: LEAD MODEL 304
• Type of Device: GENERATOR
• 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: 5150483
• MDR Text Key: 28677190
• Report Number: 1644487-2015-06108
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup
• Report Date: 09/18/2015

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: 12/31/2016
• Device Model Number: 304-20
• Device Lot Number: 3504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2012
• 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: 49 YR