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

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2016

Event Type  malfunction  

Event Description

It was reported that high impedance was observed on vns patient's system during consultation.A high impedance was noticed when the generator has been switched off before mri examination.No trauma was reported on the patient.X-rays were provided to the manufacturer for review.The review of the provided x-rays images showed that no lead bread or sharp angles were identified.The review of the manufacturing records confirmed all tests passed for the lead prior to the distribution.Follow up with the surgeon indicated that a revision surgery is planned on (b)(6) 2016.

Event Description

Follow up with the surgeon indicated that a lead replacement surgery was performed, the lead impedance returned to the normal value after the implant of the new lead (1607 ohms).The explanted lead was returned to the manufacturer.Analysis is underway but it has not been completed to date.

Event Description

The lead analysis was completed.A lead break was identified in the positive coil on the returned lead portions.Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location.However, due to metal dissolution the fracture mechanism cannot be ascertained.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Manufacturer Narrative

Date received by the manufacturer; corrected data: the previously submitted mdr inadvertently provided the wrong date.Date of report; corrected data: the previously submitted mdr inadvertently provided an incorrect report date.

• 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: 6119989
• MDR Text Key: 60966074
• Report Number: 1644487-2016-02704
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/29/2015
• Device Model Number: 304-20
• Device Lot Number: 201722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2011
• 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: 44 YR