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

Model Number 302-20

Device Problems High impedance (1291); Split (2537)

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

Event Date 06/10/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance.Pre-operative normal mode and system diagnostics revealed high impedance.When the surgeon opened the neck incision site, he observed that the lead body was in two pieces near the bifurcation.The explanted generator and lead have not been returned to date.

Manufacturer Narrative

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

Event Description

The explanted generator and lead were returned to the manufacturer for analysis.During the product analysis there were no anomalies found with the pulse generator.The generator performed according to functional specifications.Analysis of the returned lead is currently underway.

Manufacturer Narrative

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

Event Description

Analysis of the lead was completed on 08/05/2014.Scanning electron microscopy images of the broken coils and strand segments show that pitting or electro-etching conditions have occurred at the coils ends.A segment of a strand was noted at the center of coil 1.However, due to metal dissolution, mechanical distortion (smoothed surfaces) and /or surface contamination the fracture mechanism of the coils cannot be determined.Abrasions were noted on the silicone tubing of the lead coils at approximately 0.4-2.8cm past the electrode bifurcation.A suspected coil break was identified at the end of both lead coils located at approximately 2.8cm past the electrode bifurcation.The silicone tubing appears to have been torn at this location.Two strands segments became detached from the end of coil 2 during inspection of the broken end.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 opening and the ends of the returned lead portions.Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the coils.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

• 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: 3912686
• MDR Text Key: 16001179
• Report Number: 1644487-2014-01688
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2014

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: 06/30/2010
• Device Model Number: 302-20
• Device Lot Number: 200520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/05/2014
• Initial Date FDA Received: 07/03/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/04/2014; 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2007
• 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: 17 YR