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 07/01/2015

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance (dc dc code - 7).X-rays were taken and sent to manufacturer for review.Review of the x-rays identified that the lead pin was fully inserted into the generator header.There was no obvious discontinuity identified in the lead portion that was visible in the x-rays.A micro-fracture could not be ruled out.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.No known surgical interventions have been performed to date.No additional relevant information has been received to date.

Event Description

Addition information was received indicating that the patient underwent a full replacement surgery on (b)(6) 2016.The generator was replaced due to battery depletion and the lead was replaced due to high impedance.Return of the explanted devices to the manufacturer is expected but it has not been received to date.

Event Description

Further information was received indicating that the generator was prophylactically replaced.The patient's vns system was tested upon connection of the new lead to the new generator and system diagnostics returned impedance results within normal limits with dcdc code 1.The explanted lead and generator were returned to the manufacturer on 03/04/2016.Analysis is underway but it has not been completed to date.

Event Description

Analysis of the returned generator was completed.It indicates that the generator performed according to functional specifications.During the product analysis there were no anomalies found with the pulse generator.An analysis was performed on the returned lead portions and the reported allegations were confirmed.During the visual analysis of the returned portion, the (-) green electrode quadfilar coil appeared to be broken.Scanning electron microscopy (sem) was performed on the connector end of the (-) green electrode quadfilar coil break and identified the area on two of the broken coil strands as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type.The area on a third broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting.The area on the fourth broken coil strand was identified as having evidence of a stress induced fracture (rotational forces) with mechanical damage and no pitting.Pitting and flat spots were observed on the coil surface.Sem was performed on the electrode (mating) end of the (-) green electrode quadfilar coil break and identified the area on two of the broken coil strands as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type.The area on the remaining two broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type.Extensive pitting and flat spots 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.With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator.The additional 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 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.

• 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: 5074235
• MDR Text Key: 26158514
• Report Number: 1644487-2015-05775
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2011
• Device Model Number: 302-20
• Device Lot Number: 2143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2008
• 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: 40 YR