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

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Inflammation (1932); Fluid Discharge (2686)

Event Date 07/30/2015

Event Type  Injury  

Event Description

It was reported that the vns patient presented with drainage at the generator site and inflammation at the neck incision site.The patient was subsequently given antibiotics.Follow-up revealed that the infection-like symptoms were reported by the physician to be superficial, isolated to the patient¿s skin, and not related to the implanted devices.Patient manipulation or trauma is not believed to have caused or contributed to the event.Additional information was received stating that the vns patient went to the hospital as his neck incision site had opened and exposed the patient¿s lead.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was received stating that the patient's physician did not believe that the event was related to vns surgery.The patient had been seen several times following surgery and the patient's incision sites had healed well.The physician concluded that the patient's symptoms were superficial during the office visits.The incisions sites were cultured and treated with an appropriate antibiotic regiment.Patient manipulation or trauma is not believed to have caused or contributed to the event, and no known medication or diet changes preceded the onset of the event.

• 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: 4964297
• MDR Text Key: 22055668
• Report Number: 1644487-2015-05438
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: 304-20
• Device Lot Number: 3194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2011
• 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 Outcome(s): Hospitalization
• Patient Age: 15 YR