MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 303

Model Number 303-20

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Erosion (1750)

Event Date 04/01/2016

Event Type  Injury  

Event Description

It was reported that vns patient had a revision of the wound (b)(6) 2016 due to a protruding flange.It was reported that the scar had healed well after device implantation in (b)(6) 2012 and the flange only exposed in (b)(6) 2016.It was reported that flange had eroded through the skin and was replaced.Nurse cannot find the operation note on the system.It was reported that there is no mention of any weight loss in patient notes.The patient has mild learning disabilities therefore may possibly has manipulated the device however patient's mother did not seem to think this was the case.Review of manufacturing records confirmed sterilization with hp for the lead prior to distribution.

• Brand Name: LEAD MODEL 303
• 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: 5993148
• MDR Text Key: 56120265
• Report Number: 1644487-2016-02242
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 303-20
• Device Lot Number: 202176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2012
• 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: 57 YR