MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problem High impedance (1291)

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

Event Date 10/29/2014

Event Type  malfunction  

Event Description

It was reported that the patient was supposed to undergo generator replacement due to end of service on (b)(6) 2014 but pre-operative diagnostics showed high impedance.The surgery was therefore cancelled for the day.Although surgery is likely, it has not occurred to date.

Manufacturer Narrative

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

Event Description

On (b)(6) 2014 the explanted generator and lead were returned for product analysis.Product analysis is still underway and has not yet been completed.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the lead on (b)(6) 2014.The (+) white and (-) green electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the returned 125mm portion the end of the (-) green electrode tri-filar coil appeared to be broken approximately 15mm from the distal end of the anchor tether.Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type.Fine pitting was observed on two of the broken coil strands.Evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on the remaining broken coil strand.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.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.Product analysis was completed on the generator on 12/22/2014.An end-of-service warning message was verified in the pa lab.With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1.971 volts, indicating an eos condition.The data from the generator shows an increase of impedance to 9434 ohms, which occurred on (b)(6) 2014.There were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: LEAD MODEL 303
• 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: 4264382
• MDR Text Key: 16848938
• Report Number: 1644487-2014-03086
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2014

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: 03/30/2013
• Device Model Number: 303-20
• Device Lot Number: 200350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/17/2014; 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2006
• 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: 24 YR