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

Model Number 302-20

Device Problem Fracture (1260)

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

Event Date 05/10/2017

Event Type  malfunction  

Event Description

It was reported that the patient's device had high impedance, which caused low output current, on (b)(6) 2017.The patient was seen about two months prior, and there were no issues.However, the patient did have a fall between the office visits, which the physician believed was the cause of the high impedance.The patient was referred for lead revision surgery, but no surgery has occurred to date.

Event Description

The patient had full revision surgery.The generator and lead were received, but analysis has not been approved to date.

Event Description

Analysis on the generator was approved.The device performed according to functional specifications and was at an ifi=no battery condition.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis on the lead was also approved.Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.The connector ring quadfilar coil appeared to be broken near the end of the connector boot.Scanning electron microscopy was performed on the connector end of the connector ring quadfilar coil break and identified the area as being mechanically damaged with fine pitting which prevented identification of the coil fracture type.Pitting and residual material were observed on the coil surface.Scanning electron microscopy was performed on the electrode (mating) end of the connector ring quadfilar coil break and identified the area as having evidence of being worn to the point of fracture with mechanical damaged.Pitting and flat spots were observed on the coil surface.The connector ring quadfilar coil appeared to be broken past the end of the electrode bifurcation.Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having extensive pitting which prevented identification of the coil fracture type.The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type.Pitting and residual material 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.The abraded openings found on the outer and inner silicone tubes and slice mark on the outer 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 tubes.With the exception of the observed discontinuities and abraded openings, 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 set screw 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, 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
• 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: 6610159
• MDR Text Key: 76596203
• Report Number: 1644487-2017-03915
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2017

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: 06/30/2006
• Device Model Number: 302-20
• Device Lot Number: 010763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/03/2017
• Supplement Dates Manufacturer Received: 06/19/2017; 07/24/2017
• Supplement Dates FDA Received: 07/18/2017; 08/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2004
• 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