MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Erythema (1840); Itching Sensation (1943); Local Reaction (2035)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that vns patient was diagnosed with contact dermatitis after the vns implant.Follow up indicated that the reported contact dermatitis started on (b)(6) 2016 (one day before the vns implant).The reported contact dermatitis was observed on whole patient's body area; the symptoms are itching, macule, redness but no inflammation.It is not sure if this is associated with vns stimulation but it become serious after vns implantation (especially on incision site).It was reported that no medication or skincare product used could have caused that.The vns system diagnostic test result is ok.There hasn't been any intervention so far and the plan is to refer the patient to dermatologist to find out better treatment.

Event Description

It was reported that the patient was given medication for the contact dermatitis and was recovering gradually.It was also reported that the physician believed the contact dermatitis was caused by medication and not the vns implant.

• Brand Name: PULSE GEN MODEL 102
• 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: 6129416
• MDR Text Key: 60965643
• Report Number: 1644487-2016-02732
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2017
• Device Model Number: 102
• Device Lot Number: 4558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2015
• 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): Other; Required Intervention
• Patient Age: 30 YR