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

Model Number 302-20

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 11/20/2017

Event Type  malfunction  

Event Description

It was reported that a patient was getting a prophylactic replacement surgery.Diagnostics that were run before the operation and after the battery replacement indicated high impedance.The patient underwent a full revision surgery.The lead and generator were received and are currently pending analysis.

Event Description

Product analysis was completed for the explanted lead and generator.Product analysis for the generator was reviewed.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 2.658 volts as measured, showed the battery was not at an end-of-service condition.The data in memory locations revealed that 58.740% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.Product analysis for the lead was reviewed.The leads were returned in one piece, without the electrodes.A break was identified in the coil.Scanning electron microscopy images show that pitting or electro-etching conditions have occurred at the break location.Due to mechanical distortion (smoothed surfaces) and/or metal dissolution the fracture mechanism cannot be ascertained.Abrasions were noted on the outer silicone tubing at multiple locations, and were suspected to be caused by the presence of tie-downs used to secure the lead in the body.The silicone tubing was cut and the coils were kinked at various locations of the lead.These were likely caused during the explant procedure and likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.The set screw marks seen on the connector pin 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: 7128571
• MDR Text Key: 95342458
• Report Number: 1644487-2017-05030
• 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
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2012
• Device Model Number: 302-20
• Device Lot Number: 2284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Operating Room
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2009
• 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: 24 YR