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

Model Number 302-20

Device Problem Fracture (1260)

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

Event Date 03/29/2017

Event Type  malfunction  

Event Description

Clinic notes were received from a visit on (b)(6) 2017.The notes provide that the patient¿s vns showed high lead impedance.It was reported the patient¿s seizures were doing fairly well.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Full revision surgery occurred.The explanted devices have not been received by the manufacturer to-date.

Event Description

The explanted devices were received 06/21/2017.Analysis is underway, but has not been completed to-date for the lead.Analysis was completed for the returned generator 07/06/2017.The generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed the generator performed according to functional specifications.The measured battery voltage did not show a low battery condition.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

Analysis was completed on the returned lead portion.A large portion of the lead assembly was not returned and therefore a complete evaluation could not be performed.The lead coils were broken in several locations.Scanning electron microscopy was performed, and the area had evidence of a fatigue stress fracture, fine pitting and rotational stress fracture which likely completed the fracture.Pitting and residual material were observed on the coil surface.The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, likely provided the path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.For the inner tubing fluid, there was no obvious path for fluid ingress other than the cut ends that were made during the explant process.No other anomalies were noted except the set of set screw marks observed near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator, at one point in time.An additional pair of set screw marks provide evidence that, at one point in time, a good mechanical and electrical connection was present.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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: 6481653
• MDR Text Key: 72455038
• Report Number: 1644487-2017-03597
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2005
• Device Model Number: 302-20
• Device Lot Number: 009405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2003
• 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: 40 YR