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 04/08/2016

Event Type  malfunction  

Event Description

It was reported that high impedance was observed on vns patient's system.The patient was due to undergo generator replacement surgery, when high impedance was identified; the vns patient's device was tested and system mode diagnostic results revealed high impedance (dc dc code 7) and near end of service = no.It was reported that the device replacement surgery was performed.The patient's vns system was tested upon connection of the new generator to the existing lead and high impedance persisted.It was reported that the newly implanted device was disabled.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.Additional information was received indicating that the generator was replaced due to battery depletion.The return of that explanted device to the manufacturer is expected but it has not been received to date.It was reported that a lead revision due to lead discontinuity is planned.No known surgical interventions have occurred to date.

Event Description

The explanted generator was received to the manufacturer on 04/28/2016.Analysis of the returned generator was completed.The generator performed according to functional specifications.During the product analysis there were no anomalies found with the pulse generator.

Event Description

Further information was received indicating that the patient underwent lead replacement surgery on (b)(6) 2016.The lead was replaced due to lead discontinuity.The patient's vns system was tested upon connection of the new lead to the generator and system diagnostics returned impedance results within normal limits with 1568 ohms.The explanted lead was returned to the manufacturer on 06/09/2016.Analysis is underway but it has not been completed to date.

Event Description

An analysis was performed on the returned lead portions and the reported allegations of "fracture of leads" were confirmed.Note that the (-) green electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the returned 40mm portion the (+) white electrode quadfilar coil appeared to be broken approximately 19mm from the electrode bifurcation.Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type.Pitting was observed on the coil surface.During the visual analysis of the returned 9mm portion the end of the (+) white electrode quadfilar coil appeared to be broken approximately 18mm past the end of the cut inner silicone tubing.Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting.The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture with pitting.Flat spots and pitting were observed on the coil surface.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 in various locations.Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium.During the visual analysis the (+) white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue.This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve.With the exception of the observed discontinuity and the tissue-covered (+) white electrode ribbon 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 pins 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 findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of high impedance.Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.However, the positive electrode condition may have contributed to the reported ¿high impedance¿.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 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: 5614469
• MDR Text Key: 44704001
• Report Number: 1644487-2016-00917
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup,Followup,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2008
• 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: 16 YR