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

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 02/03/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and multiple system diagnostic results revealed high impedance (impedance value >= 10,000 ohms).The patient¿s device was subsequently disabled.The patient¿s device was last tested on (b)(6) 2012 and system diagnostic results showed lead impedance within normal limits (impedance value ¿ 3225 ohms).X-rays 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.The electrodes appeared to be placed in normal arrangement.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.A suspect area was identified distal to the positive electrode.Based on the images provided, the cause of the high lead impedance remains unknown.No known surgical interventions have occurred to date.

Event Description

It was reported that the patient underwent generator and lead replacement.Device diagnostics with he new vns system were within normal limits.The explanted generator and lead were received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Product analysis of the generator did not confirm the reported battery depletion and revealed that the device had not reached the ifi point and just under 25% of the battery had been consumed.Review of the internal device information shows an indication of increased impedance consistent with the initial report.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis of the lead confirmed discontinuity of positive coil at two locations in the electrode region of the returned lead portions.Scanning electron microscopy images of the positive coil breaks show that pitting or electro-etching conditions have occurred at the break locations.However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination the fracture mechanism cannot be ascertained.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 cut ends of the returned lead.Based on the appearance of the returned lead portions, it is believed that identified punctures, kinks, tubing cuts, 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.

Manufacturer Narrative

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

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a 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: 4210668
• MDR Text Key: 5148708
• Report Number: 1644487-2014-02881
• 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: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: 302-20
• Device Lot Number: 2873
• 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
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2010
• 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