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

Model Number 304-20

Device Problem Scratched Material (3020)

Patient Problem Wound Dehiscence (1154)

Event Date 05/16/2016

Event Type  Injury  

Event Description

A report was received indicating that a patient's lead site incision had opened up and the implanted lead was exposed.Surgery to repair the incision was scheduled.Follow up with the provider indicated that on (b)(6) 2016 the provider successfully repaired the incision wound opening and was able to leave the implanted system intact; no devices were removed, explanted, or replaced.The patient has not returned for follow-up but the provider indicated they believe the patient is healing fine.The provider indicated the patient was seen in (b)(6) 2016 and there were no issues at that time.The cause of the lead extrusion is unknown per the provider.

Manufacturer Narrative

The manufacturer's initial mdr report inadvertently did not include the suspect device udi.The suspect udi should have been reported as (b)(4).

• 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: 5708741
• MDR Text Key: 46884382
• Report Number: 1644487-2016-01292
• 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
• Report Date: 05/18/2016

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: 04/13/2019
• Device Model Number: 304-20
• Device Lot Number: 203357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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: 26 YR