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

Device Problems Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)

Patient Problem Seizures (2063)

Event Date 01/18/2016

Event Type  malfunction  

Event Description

It was reported that a patient was having an increase in seizures that was below the patient's pre-vns baseline frequency over the past few months.The patient used to have daily seizures, and then she started having several cluster seizures per day.Also, the magnet was not aborting seizures as it used to.The patient also did not cough when her settings were increased or hoarseness like she usually did.Normal mode diagnostics were performed, which resulted in dcdc code 0.However, it could not be determined if low impedance was present since system diagnostics were not performed.System diagnostics were performed, which resulted in dcdc code 0, indicating a short-circuit condition.The patient was referred for revision surgery, but no surgery has occurred to date.

Event Description

The patient had full revision surgery on (b)(6) 2016.The explanting facility will not return the devices to the manufacturer.Therefore, no analysis could be performed.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 5672397
• MDR Text Key: 46716944
• Report Number: 1644487-2016-01096
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 26 YR