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

Model Number 106

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Chest Pain (1776); Fever (1858); Pain (1994); Loss of consciousness (2418); No Code Available (3191)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was experiencing pain where her vns implant is in the chest and down her left arm.The vns generator was also reportedly protruding from her skin.She had passed out at the time this started, and she was also experiencing a low-grade fever.Follow up with the surgeon's office showed that the patient came in for an appointment, and surgery was planned to remove her vns.It was reported that this was upon patient request on not wanting the vns anymore.However, insufficient information was given on what role the reported symptoms had in the decision to explant the device.Surgical intervention has not occurred to date.A review of device history records showed that both the lead and generator were sterilized prior to distribution.

Event Description

The explanted generator was reported to have been discarded following the explant surgery.No additional pertinent information has been received to date.

Event Description

The patient had her vns generator explanted on (b)(6) 2016.The explanted generator has not been returned to the manufacturer to date.Follow up communication with the explanting surgeon determined that, in his medical opinion, there was no indication of an underlying infection or site reaction.He believed the patient perceived the device as being uncomfortable.The surgical intervention taken was not to preclude a serious injury.There was no trauma or other external factors that were contributing to the reported symptoms.No additional pertinent information has been received to date.

Event Description

Additional information received showed that the patient had her vns removed due to pain from the size of the generator.Clinic notes showed that the device had also migrated from its original implant location prior to removal.No additional pertinent 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: 5939462
• MDR Text Key: 54322122
• Report Number: 1644487-2016-02029
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2017
• Device Model Number: 106
• Device Lot Number: 203831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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: 35 YR