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

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Seizures (2063)

Event Date 05/29/2014

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in low lead impedance (600 ohms).It was reported that the last known good diagnostics were on (b)(6) 2014.The patient was referred for x-rays which showed "curled wires".It was reported that the patient's seizures have gotten stronger, but that this was below pre-vns baseline.X-rays were sent to manufacturer for review.X-rays identified a lead break and noted that the lead appeared to be twisted at the connector pin.It was reported that the patient would be referred for surgery.The device was not programmed off after observing the low impedance.No surgical intervention has been performed to date.

Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014.The explanted devices have not been returned to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.Review of x-rays by the manufacturer revealed a gross lead discontinuity.Device failure occurred, 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: 3900745
• MDR Text Key: 4546572
• Report Number: 1644487-2014-01622
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 06/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2014
• 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 Age: 16 YR