MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 01/09/2014

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance (dc dc code - 7).It was reported that no trauma occurred that is believed to have caused or contributed to the high impedance.Clinic notes dated (b)(4) 2014 note that the patient has experienced daily seizures.It was noted that the patient's mother has been compliant with the medications.It was noted that the diagnostics showed an abnormal reading and that a second diagnostic test was run which showed ok lead impedance.It was noted that the third diagnostic was normal.The notes indicate that irregular diagnostics have been seen in the past.The notes indicate that the patient's seizures have increased from weekly to daily.Further follow-up revealed that the physician does not know if the seizures are an increase above the patient's pre-vns baseline.The physician was unsure if the increased seizures are a result of the patient's lennox gastau or the high impedance.The patient was referred to surgeon for device replacement.Surgery is likely, but has not occurred to date.

Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014.Pre-operative diagnostic results showed high lead impedance (dc dc - 7).The lead was observed to be broken approximately 3-4 inches from the generator header.The surgeon noted that the lead appeared to be worn down which he believed was due to the lead rubbing against the generator and the patient¿s rib.The lead was cut below the anchor tether and explanted.The surgeon elected to leave the electrodes and anchor tether intact on the patient¿s nerve.The replacement lead was placed above the old electrodes.The replacement generator was placed in the existing generator pocket.The patient¿s replacement devices were tested outside and inside the generator pocket and diagnostic results showed lead impedance within normal limits.The patient¿s device was not programmed on following surgery.The suspect medical device has not been returned to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.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 or serious injury.

Event Description

The generator and lead were received for analysis.Analysis of the lead was completed on (b)(4) 2014.Note that a portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis abraded openings were observed in several areas of the outer and inner silicone tubes.The positive connector ring quadfilar coil appeared to be broken approximately 21mm from the end of the connector boot.Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type.A loose piece of broken negative connector pin quadfilar coil was observed inside the inner silicone tubing approximately 30mm from the end of the connector boot.Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots and pitting on the coil surface.The negative connector pin quadfilar coil appeared to be broken approximately 52mm from the end of the connector boot.Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting.During the visual analysis of the returned 281mm portion quadfilar coil breaks were observed at 57mm from the area of the abraded opening, 85mm from the end of the abraded opening, and 117mm from the abraded opening.Scanning electron microscopy was performed and found that the area showed evidence of being worn to the point of fracture.Quadfilar coil 2 appeared to be broken approximately 145mm from the area of the abraded open outer / inner silicone tubes.Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.What appeared to be white deposits were observed on the outer silicone tubing.Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium and calcium.With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.Based on the diagnostic results, a short-circuit condition appears to have existed.Analysis of the generator was completed on (b)(4) 2014.The generator performed according to functional specifications.During the product analysis there were no anomalies found with the pulse generator.

Manufacturer Narrative

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

• Brand Name: LEAD MODEL 302
• 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: 3672624
• MDR Text Key: 4319657
• Report Number: 1644487-2014-00659
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/25/2005
• 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: 15 YR