MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem Swelling (2091)

Event Date 02/28/2017

Event Type  Injury  

Event Description

It was reported by the physician that he did not program the patient's vns on because the patient's neck incision was a "little puffy"; and he wanted to wait.The physician stated he did not believed there was an infection, but he was being extra cautious.Review of the device history record for both the lead and the generator confirmed sterilization prior to distribution.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported the physician saw the patient again.The physician noted the incision site looked good and there were zero side effects.The puffiness the patient had has now resolved.

• Brand Name: PULSE GEN MODEL 103
• 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: 6484497
• MDR Text Key: 72497128
• Report Number: 1644487-2017-03602
• 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: 05/01/2017

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: 05/15/2017
• Device Model Number: 103
• Device Lot Number: 203431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 04/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2015
• 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: 22 YR