MAUDE Adverse Event Report: CYBERONICS LEAD MODEL UNKNOWN

Device Problems Fracture (1260); High impedance (1291)

Patient Problem Seizures (2063)

Event Date 02/04/2016

Event Type  malfunction  

Event Description

It was reported that high impedance (dcdc 7) was observed on vns patient's system.Normal mode and system mode diagnostics were run and high impedance were found (dcdc 7).It was reported that the device was then disabled.X-rays were taken and sent to 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 is fully inserted into the generator connector block.The electrode appears to be placed in abnormal arrangement (the negative electrode appears to be placed distal to head) but this could not be confirmed due to poor quality of the image.It's unable to assess if the strain-relief bend and loop are presents.No tie-down was found holding the lead.A portion of lead behind the generator could not be assessed.No suspected lead break was found on the visible part of the lead.Further information was received from the physician, indicating that the patient's generator was implanted in 2014.It's unknown if any patient trauma or manipulation occurred that could be the cause of the suspected lead fracture.As reported by the parents to the physician, the patient's seizures were stable until (b)(6) 2016, without explanation.The last device checking in (b)(6) 2015 found that the parameters / settings were normal.During a clinic visit on (b)(6) 2016, high impedance was found.The device was then switched off that day.It was reported that lead revision is planned.No known surgical interventions have been performed 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: 5488882
• MDR Text Key: 40255012
• Report Number: 1644487-2016-00502
• 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: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• 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: 02/17/2016
• 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 Age: 25 YR