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

Model Number 302-20

Device Problems Break (1069); Circuit Failure (1089); Fracture (1260); Leak/Splash (1354); Material Integrity Problem (2978); Naturally Worn (2988)

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

Event Date 01/01/2013

Event Type  malfunction  

Event Description

Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.It was reported that the last known normal diagnostic results occurred during an office visit on (b)(6) 2012.

Manufacturer Narrative

Review of the available programming and diagnostic history.Age at time of event, corrected data: the initial manufacturer report inadvertently did not update the patient's age at the time of the event as the lead fracture occurred prior to replacement surgery.Date of event, corrected data: the initial manufacturer report inadvertently did not update the date of event as the lead fracture occurred prior to replacement surgery.

Event Description

It was reported that during generator replacement surgery on (b)(6) 2014 due to battery depletion, the surgeon cut the vns patient¿s lead so the lead was also replaced during the procedure.The explanted generator and lead were returned to the manufacturer for analysis.Analysis of the returned lead portion determined that the patient's lead was fractured prior to replacement.During the visual analysis of the returned lead portion, the (-) connector pin quadfilar coil appeared to be broken approximately 110mm 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 the (+) connector ring quadfilar coil appeared to be broken approximately 129mm 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.Pitting was observed on two of the broken coil strands and 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.The abraded openings found on the outer and inner silicone tubes 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 tubes.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.Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.The end of service for the returned generator was determined to be the result of normal battery depletion.The depletion was an expected event as determined by blc and battery voltage measurement.The module performed according to functional specifications.There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

Manufacturer Narrative

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

• 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: 3923737
• MDR Text Key: 4623912
• Report Number: 1644487-2014-01741
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2010
• Device Model Number: 302-20
• Device Lot Number: 200419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2007
• 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: 9 YR