MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNK; GENERATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Unspecified Infection (1930); Burning Sensation (2146)

Event Date 09/19/2014

Event Type  Injury  

Event Description

It was reported that the neurologist noted redness at the generator site and thought the surgeon should order antibiotics.The patient denied pain or drainage but indicated that the generator site was warm.The patient later reported that she was seen by her primary care physician for an upper respiratory infection and that the antibiotics she was given for that also decreased the redness to the generator site.The patient has been applying neosporin to the incision sites and the chest incision is now light pink and no longer feels warm.

Event Description

Additional information was received stating that the patient went to the er on (b)(6) 2014 due to chest pain associated with stimulation.The er physician was advised to use the magnet to temporarily disable the device.Further follow up with the physician's office indicated that the patient had recovered from infection on (b)(6) 2014.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4262265
• MDR Text Key: 5103594
• Report Number: 1644487-2014-03078
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/20/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 11/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 50 YR