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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms).The patient¿s device was subsequently disabled.X-rays dated were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin cannot be confirmed to be fully inserted into the generator connector block.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Based on the images provided, the cause of the high lead impedance remains unknown.Follow-up revealed that the patient underwent surgery on (b)(6) 2014.Pre-operative system diagnostics showed high impedance (impedance value >= 10,000 ohms).A replacement generator was connected to the existing lead tested with the existing lead and system diagnostic results showed lead impedance within normal limits (impedance value ¿ 3708 ohms and 4111 ohms).The surgeon believed that incomplete lead pin insertion was the cause of the high impedance condition so the lead was not replaced during the procedure.When the patient was closed and dressed, the surgeon tested the device multiple times and high impedance was observed (impedance value >= 10,000 ohms).It was noted that the patient¿s body position remained mostly unchanged during the procedure.The patient was referred for additional surgery, but surgery has not occurred to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Analysis of the returned lead was completed which confirmed discontinuity of the negative quadfilar coil in the electrode region.Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location.However, due to pitting, mechanical distortion (smoothed surfaces) and surface contamination the fracture mechanism cannot be determined.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions.Based on the appearance of the returned lead portions, it is believed that the identified punctures, kinks, superficial cuts/scratches, and tubing cut openings were most likely caused during the explant procedure.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Manufacturer Narrative

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

Event Description

Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014.The explanted lead has been returned to the manufacturer where analysis is currently underway.

• 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: 4326952
• MDR Text Key: 5245233
• Report Number: 1644487-2014-03301
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2014

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: 05/31/2014
• Device Model Number: 302-20
• Device Lot Number: 2658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/16/2015; 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2010
• 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