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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Edema (1820); Unspecified Infection (1930)

Event Date 04/18/2017

Event Type  Injury  

Event Description

It was reported that a patient developed an infection at his generator site shortly after vns surgery.Antibiotics were administered when the infection first appeared, and the infection began to recede.No additional medical intervention was taken for the patient's infection.No additional relevant information has been provided to date.No surgical intervention has occurred to date.

Event Description

Progress notes from the patient's surgeon indicated that the patient experienced swelling at his generator site.Specimens were taken from the neck incision site and no infections were identified.The patient's generator incision site also had a slight wound opening of 2-3 mm.The patient reportedly had a massive keloid which the physician believed contributed to the patient's swelling and wound dehiscence.The patient was given antibiotics.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL UNKNOWN
• Type of Device: GENERATOR
• 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: 6610062
• MDR Text Key: 76586165
• Report Number: 1644487-2017-03910
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/27/2017
• 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): Other
• Patient Age: 33 YR