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

Device Problem Low impedance (2285)

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

Event Date 04/16/2015

Event Type  malfunction  

Event Description

Clinic notes were received indicating that during an office visit on (b)(6) 2015, the vns patient was no longer experiencing any falls or injuring herself as magnet mode stimulation had been successful in aborting the patient¿s seizures.The patient was able to go 20 days without experiencing a seizure but at times had a couple seizures per week.Notes dated (b)(6) 2015 state that the patient had been experiencing an increase in seizures the previous two weeks.The device was tested and normal mode diagnostic results revealed a low impedance condition (impedance value <= 600 ohms).Patient manipulation or trauma is not believed to have caused or contributed to the low impedance condition.The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description

It was reported that the vns patient's device showed low impedance.No known surgical interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013.

Event Description

Analysis of the returned generator and lead was completed.There were no performance or any other type of adverse conditions found with the pulse generator.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Based on the condition of the as-received lead, it is possible that at one time the bare and exposed conductive quadfilar coils may have been in contact with one another.During visual analysis, the quadfilar coil appeared to be stretched and twisted.Scanning electron microscopy was performed and identified the areas as having evidence of a stress induced fracture (torsional appearance) with mechanical damage and secondary break lines.Pitting was observed on the coil surface.The abraded openings most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes.Based on the overall condition of the returned lead assembly, there appears to be evidence of manipulation, which may have contributed to the observed stress-induced fracture.

Manufacturer Narrative

Review of the available programming and diagnostic history.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death.

Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

• 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: 4760159
• MDR Text Key: 5927081
• Report Number: 1644487-2015-04652
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 4 YR