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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 02/15/2015

Event Type  malfunction  

Event Description

It was reported that the patient's vns system was interrogated and high lead impedance was registered.The patient was referred for full revision surgery.No surgical interventions have occurred to date, and no additional pertinent information has been received to date.

Event Description

It was reported that the patient's full vns replacement surgery was completed on 07/08/2016.The explanted lead and generator were received by the manufacturer on 07/21/2016 for product analysis.Product analysis for the explanted lead was completed on 08/02/2016.An abraded opening was noted on the inner silicone tubing of the negative coil past the electrode bifurcation.A break was identified in the negative quadfilar coil.Scanning electron microscopy images of the negative coil break show that pitting or electro-etching conditions have occurred at the break location.The negative quadfilar coil has two secondary fractures on one strand prior to and past the break location.Pitting or electro-etching conditions were also noted in the vicinity of one of the secondary broken strands.Due to mechanical distortion or metal dissolution, the fracture mechanism of the broken strands cannot be ascertained.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.No additional pertinent information has been received to date.

Event Description

Product analysis was completed on the returned generator on 08/15/2016.Other than observations associated with the device explant procedure, no surface abnormalities were noted on this device during visual analysis.Review of the internal device data downloaded from the pulse generator shows an indication of a change to high lead impedance (2986 ohms pre-change to 11629 ohms post-change) at an estimated date of (b)(6) 2015.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery was 3.044 volts as measured in the final electrical test showed an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 5517189
• MDR Text Key: 41175991
• Report Number: 1644487-2016-00595
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2004
• Device Model Number: 302-20
• Device Lot Number: 7342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2002
• 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: 27 YR