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

Model Number 302-20

Device Problems High impedance (1291); Failure to Advance (2524)

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

Event Date 05/19/2016

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2016 that the patient's vns system registered high lead impedance.X-ray images of the patient's vns system were received by the manufacturer and subsequently reviewed.There was one image provided that could be reviewed.The generator was placed normally per labeling.The connector pin of the lead could be confirmed to be fully inserted inside the connector block.The feed thru wires appeared intact.The location of the electrodes appeared to be placed per labeling.A small portion of the lead was behind the generator, making the lead difficult to assess in this area.There were two places where there were apparent sharp angles in the lead.There were no apparent gross fractures of the lead that could be seen in the images given.The wires at the lead connector pin appeared to be intact.From the x-rays received, the cause for the reported high impedance could not be determined.Although there were apparent sharp angles in the lead, this could not be confirmed to be indicative of device damage.There was nothing seen that would indicate there was damage to the generator or lead.However, the presence of a micro-fracture in the lead cannot be ruled out.Surgical intervention has not been reported to have occurred to date.No additional pertinent information has been received to date.

Event Description

The patient vns system was fully replaced in surgery on (b)(6) 2016.The explanted products were received by the manufacturer on 10/14/2016 and are undergoing product analysis.No additional pertinent information has been received to date.

Event Description

Product analysis was completed for the returned generator.Visual examination identified only explant related observations.No surface abnormalities were noted on this device.The device performed according to functional specifications.The can was inadvertently opened.Measurements of the device battery voltage and current drain were as expected, confirming that the battery was not at an eri condition.No internal visual anomalies were identified.No abnormal performance or any other type of adverse condition was found.Product analysis was performed on the returned lead portion.Note that the electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead.The connector pin quadfilar coil appeared to be broken in two places, approximately 231mm and 255mm from the end of the connector boot.Scanning electron microscopy (sem) was performed and identified the areas as being mechanically damaged and/or having extensive pitting, which prevented identification of the coil fracture type(s).The connector ring quadfilar coil appeared to be broken in two places, approximately 244mm and 255mm from the end of the connector boot.Sem was performed on the connector ring quadfilar coil break at 244mm and identified the area as being mechanically damaged and pitted, which prevented identification of the coil fracture type.Sem was performed on the connector ring quadfilar coil break at 255mm and identified the area on three of the broken coil strands as having evidence of a stress-induced fracture.The fourth coil showed mechanical damage and pitting, which prevented identification of the coil fracture type.Abraded openings were located on the outer and inner silicone tubes, and 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 tubing.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Continuity checks of the returned lead portion were performed, and no other discontinuities were identified.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.

• 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: 5755153
• MDR Text Key: 49145080
• Report Number: 1644487-2016-01452
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2016

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: 10/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/21/2016; 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2005
• 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: 49 YR