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

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 06/02/2014

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance.It was reported that x-rays were taken and did not identify any lead discontinuity; however, a portion of the lead was not visible.The patient was seen again and subsequent device diagnostics resulted in high impedance (dc dc code - 7).The device was programmed off and the patient was referred for surgery.No surgical intervention has been performed to date.

Event Description

Additional information was received stating that the vns patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 7).

Manufacturer Narrative

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

Event Description

Follow-up revealed that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance.The explanted devices have not been returned to date.

Manufacturer Narrative

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

Event Description

The explanted lead and generator were received for analysis.Analysis of the generator was completed on 01/07/2015.Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.Analysis of the lead was completed on 01/09/2015.During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 233mm and 241mm from the end of the connector boot.Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 233mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type.Pitting was observed on the coil surface.Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 241mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of the broken coil strands.The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture.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.The abraded openings found on the outer and 1 inner silicone tubing 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 tubing.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, zirconium, magnesium, sulphur and calcium.With the exception of the observed discontinuities the condition of the returned lead portion 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 portion were performed, during the visual analysis, and no other discontinuities were identified.

• 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: 3909752
• MDR Text Key: 4666004
• Report Number: 1644487-2014-01666
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup,Followup
• Report Date: 06/04/2014

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
• Device Expiration Date: 01/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 07/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/05/2014; 12/05/2014; 01/12/2015
• 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 Age: 19 YR