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

Device Problems High impedance (1291); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2015

Event Type  malfunction  

Event Description

It was reported that the patient underwent explant surgery following an infection reported in the mfr.Report # 1644487-2015-04630.

Event Description

It was reported that the recently implanted vns patient¿s device was tested two days following implant on (b)(6) 2015 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms).The patient¿s device was tested again at the second follow-up visit on (b)(6) 2015 and lead impedance was found to be within normal limits.X-rays were received by the manufacturer for review.The generator appears in the upper left chest in a normal placement.The filter feed-through wires appeared to be intact.The lead connector pin was fully inserted into the generator connector block.The electrodes appeared to be placed in normal arrangement but not aligned, though this is likely due to the position of the patient¿s head while taking the x-rays.Part of the lead was behind the generator and could not be reviewed.No clear lead breaks or sharp angles were visible.No known interventions have occurred to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.Device failure is suspected, but did not cause or contribute to a death or serious injury.

• 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: 4631956
• MDR Text Key: 5951449
• Report Number: 1644487-2015-04216
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: No
• 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: 04/29/2015
• 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