MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 04/07/2015

Event Type  Injury  

Event Description

It was reported on (b)(6) 2015 from the patient who reported a painful red lump having appeared on his neck within the last few months.The patient was implanted in (b)(6) 2014.The patient stated that the area looks kind of infected and has a large knot on it.He reported pain at the site and redness on the mass.It was recommended he contact his physician or surgeon regarding the issue.Follow-up with his physician showed that the patient did not show for two of his scheduled appointments.Therefore, no additional information has been obtained.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

• 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: 4743698
• MDR Text Key: 5828463
• Report Number: 1644487-2015-04597
• 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: Consumer,Health Professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/07/2015

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: 01/31/2018
• Device Model Number: 304-20
• Device Lot Number: 202771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2014
• 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): Other
• Patient Age: 31 YR