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

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 01/22/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device showed high impedance (dcdc ¿ 4).The patient had been experiencing an increase in seizures.The patient was last seen in (b)(6) 2014 and no issues were noted at that time.X-rays were taken and were reported by the physician to be unremarkable.X-rays dated (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 appears fully inserted into the generator connector block.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.Follow-up revealed that the patient¿s device was tested again on (b)(6) 2015 and system diagnostic results showed lead impedance within normal limits.It was noted that the patient¿s device output current had been decreased from 2.5ma to 1.75ma so the issue may have been due to device settings.The patient was referred for surgery but no known surgical interventions have occurred to date.

Manufacturer Narrative

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

Event Description

X-rays that were provided to the manufacturer for review were not dated.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.Review of the available programming and diagnostic history.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.Describe event or problem; corrected data: the previously submitted mdr inadvertently stated that the x-ray images were dated (b)(6) 2014.The images did not contain a date.Evaluation codes, methods, results; additional manufacturer narrative and/or corrected data; corrected data: the previously submitted mdr inadvertently did not provide this information based on the available information.Method and results should have been provided along with explanations.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 4524501
• MDR Text Key: 5411501
• Report Number: 1644487-2015-03879
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• 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
• Date Manufacturer Received: 03/02/2015
• 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): Required Intervention