MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Purulent Discharge (1812); Erythema (1840)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient who is subject to a (b)(6)study had the vns neck site red with a visible area of puss present.The severity of the event was moderate.It was reported that the event was unlikely related to study therapy, not related to implant nor to vns stimulation.It was reported that the treatment was not changed but the medication was added.It was reported that the patient is recovering.The event was not indicated as a serious adverse event.Additional information indicated that this adverse event could be related to a "septic arthritis", which occurred after a motorcycle accident the patient had on (b)(6) 2016.Review of manufacturing records confirmed sterilization for the lead prior to distribution.The vns patient's device was tested on 06/05/2016 and system diagnostics returned impedance results within normal limits with 3821 ohms.

Event Description

Update received states the drainage and redness as previously report appears to have resolved.Medications were noted to have been provided.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 5722869
• MDR Text Key: 47319486
• Report Number: 1644487-2016-01338
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

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: 09/30/2017
• Device Model Number: 106
• Device Lot Number: 4521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: 02/27/2018
• Supplement Dates FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2015
• 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 Age: 11 YR