MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem High impedance (1291)

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

Event Date 12/12/2014

Event Type  malfunction  

Event Description

It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the vns patient¿s replacement generator was tested with the existing lead and system diagnostics results revealed high impedance.The lead pin was confirmed to be fully inserted into the generator header.Pre-operative diagnostics could not be performed due to the end of service condition.The patient¿s lead was also replaced during the procedure.The explanted devices have been returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the returned devices was completed.Analysis of the explanted and opened/unused generators concluded that no abnormal performance or any other type of adverse condition was found.The devices performed according to functional specifications.Analysis of the returned lead confirmed discontinuity of 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.Due to pitting, 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 portions.

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 death or serious injury.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 4404879
• MDR Text Key: 5308358
• Report Number: 1644487-2015-03585
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2002
• Device Model Number: 300-20
• Device Lot Number: 813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2000
• 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: 41 YR