MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 302

Model Number 302-20

Device Problem Break (1069)

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

Event Date 12/01/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent a full vns system removal on (b)(6) 2015 due to lack of efficacy.No information about the reason for this lack of efficacy was reported.The explanted lead and generator were returned on (b)(6) 2016 for analysis.The analysis of the lead revealed a break in the negative coil.This break could be a contributing factor of the reported lack of efficacy.Analysis of the returned lead indicated that a break was identified in the negative coil.Scanning electron microscopy (sem) images of the coil verified that a break has occurred on the negative coil.Sem of broken mate end show that pitting or electro-etching conditions have occurred on one strand of the quadfilar coil.Due to mechanical distortion (smoothed surfaces) the fracture mechanism of the coil 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.Analysis of the returned generator showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The generator performed according to functional specifications there was no anomalies found with the pulse generator.Review of manufacturing records confirmed that the lead and the generator passed all functional tests prior to distribution.No additional relevant information was received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 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: 5456672
• MDR Text Key: 39418120
• Report Number: 1644487-2016-00398
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2014
• Device Model Number: 302-20
• Device Lot Number: 2629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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: 60 YR