MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 04/18/2017

Event Type  malfunction  

Event Description

A system diagnostic test was performed and showed high impedance.It was also reported that patient had been manipulating the device by rotating the generator in the surgical pocket.X-ray images were reviewed by the physician and reportedly confirmed a lead fracture had occurred.The patient had a full revision surgery to replace the fractured lead and generator, and the post-op impedance values were within normal limits.While in surgery, it was reported that the lead was extremely twisted and coiled up.The explanted lead and generator have not been received by the manufacturer to date.

Event Description

The explanted generator and lead were both returned for product analysis.Analysis was completed on the returned generator which confirmed that the generator had performed according to all functional specifications.All diagnostic tests resulted in impedance values within expected limits for the applied loads.Data from the generator revealed that high impedance was present prior to the generator being replaced.The analysis on the lead has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

Analysis was completed on the returned lead portions, which did not include the electrodes.During the visual analysis, the outer silicone tubing had a twist and compressed appearance.Additionally, several abraded openings were identified on the lead tubing and the quadfilar coil was found to be broken approximately 3 mm from the electrode bifurcation.Scanning electron microscopy (sem) was performed on the broken coil and was unable to identify the coil fracture type.The abraded openings on the outer silicone tubing provided a leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.The set screw marks found on the lead connector pin provided evidence that at one point in time, there was a good mechanical and electrical connection between the lead and generator.Other than the abraded insulation and the lead fractures identified in the lab, the condition of the returned lead was consistent with those typically seen following explant.

• Brand Name: LEAD MODEL 304
• 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: 6547477
• MDR Text Key: 74595118
• Report Number: 1644487-2017-03725
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 304-20
• Device Lot Number: 202579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 YR
• Event Location: Other
• Date Manufacturer Received: 06/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2013
• 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: 5 YR