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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device showed high impedance.The patient had been experiencing an increase in seizures for the past few weeks.The patient underwent generator and lead replacement surgery on (b)(6) 2015.The explanted devices have not been returned to date.

Event Description

The explanted lead was received by the manufacturer on 02/23/2015 and is currently undergoing analysis.

Event Description

Analysis of the lead was completed on 03/16/2015 and it identified a break in the positive coil with pitching and electro-etching at the break location.The appearance of one strand of the positive coil broken end suggest that the fracture could be induced by stress, but it cannot be confirmed due to mechanical distortion, pitting and surface contamination.Additionally, abraded openings of the outer and inner silicone tubing were identified.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 portion.

Manufacturer Narrative

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

Manufacturer Narrative

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

• 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: 4519312
• MDR Text Key: 5491885
• Report Number: 1644487-2015-03849
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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 Outcome(s): Required Intervention
• Patient Age: 17 YR