MAUDE Adverse Event Report: CYBERONICS LEAD MODEL UNKNOWN

Device Problems Fracture (1260); High impedance (1291); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2015

Event Type  malfunction  

Event Description

It was reported that high impedance (dc dc code - 7) was observed on vns patient's system.The device was then disabled.No patient adverse events were reported.X-rays were taken and sent to the manufacturer for review.The generator appears to be placed in the middle of the chest not as recommended in our labeling.The pin connector appears to be fully inserted.The electrodes appeared to be placed in abnormal arrangement: seems to be implanted too low in the neck, in the upper chest.It's unable to assess if a strain relief or loop were used, due to the quality of the provided x-rays.One tie-down was found holding the lead but not as specified by labeling.There is a large portion of the lead coiled around the electrode, which is unable to be assessed.There is no lead behind the generator.No clear lead breaks or sharp bends were found in the visible parts.A micro-fracture could not be ruled out.No known surgical interventions have been performed to date.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 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: 5251293
• MDR Text Key: 32377442
• Report Number: 1644487-2015-06563
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2015

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: 11/03/2015
• Initial Date FDA Received: 11/25/2015
• 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 Age: 14 YR