MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problem Pain (1994)

Event Date 10/12/2016

Event Type  Injury  

Event Description

It was reported by the patient's mother that the patient was experiencing painful stimulation when using the vns magnet.It was stated they had communicated the pain to the physician and the physician decreased the vns settings as they believed this would resolve the pain; however, the pain continued.It was noted the patient has fallen a few times, but the mother was unaware of any other trauma which could have caused the pain.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The event of painful magnet mode stimulation did not lead to a death or serious injury, nor would it be expected to lead to a death or serious injury if it were to recur.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later noted the patient was referred for a revision and that there was a possible lead pin insertion issue.No known surgical interventions have occurred to date.

Event Description

An implant card was later received showing the patient had undergone a full revision surgery.The vns generator replacement was prophylactic and the lead replacement was because the "leads were uncoiled due to tension." attempts for additional relevant information have been unsuccessful to date.The explanted lead and generator are not expected to be returned to the manufacturer for analysis.

• Brand Name: PULSE GEN MODEL 105
• 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: 6230577
• MDR Text Key: 64085650
• Report Number: 1644487-2017-02994
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Model Number: 105
• Device Lot Number: 3888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 2 YR
• Event Location: Other
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2014
• 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: 27 YR