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

Model Number 304-20

Device Problem Extrusion (2934)

Patient Problem Injury (2348)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

It was reported on (b)(6) 2016 that the patient has an extrusion through her skin at her neck incision.The physician does not believe that there is an infection involved based on culture results.The patient¿s device were explanted on (b)(6) 2016.The design history records for the lead and generator were reviewed on 11/29/2016.Both devices were hp sterilized prior to distribution into the field.The explanted devices were received for analysis on 12/13/2016.Analysis is underway but has not been completed to date.

Event Description

Additional information was received from the physician that the believed cause of the extrusion is patient anatomy as patient is thin and has fragile tissue.The lead assembly was returned for analysis due to the extrusion of the lead and tie down.Verification of the reported extrusion is beyond the scope of the activities performed in the pa laboratory.Since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.Analysis of the generator is underway but has not been completed to date.

Event Description

The pulse generator diagnostics were as expected for the programmed parameters.The pulse generator performed according to functional specifications (final configuration r-wave test).A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse condition found with the pulse generator.

• 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: 6178175
• MDR Text Key: 62540028
• Report Number: 1644487-2016-02875
• 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,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2020
• Device Model Number: 304-20
• Device Lot Number: 4779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2017; 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• 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: 8 YR