MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problems Ecchymosis (1818); Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 11/03/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.

Event Description

It was reported that a patient had her vns generator explanted due to infection at the generator site.The infection was reported to have "eroded straight through to the battery pack".A device history review showed that both the generator and the lead were sterilized prior to distribution.As indicated through a follow-up with the surgeon's, the patient's generator was removed with no complications.The surgeon did not know the reason for the infection, but the nurse indicated that the patient is severely autistic and mentally and physically delayed.It was suspected that the infection may have been due to patient manipulation to the site, although this could not be confirmed.The patient's generator was implanted in 2016, so the reason for infection is not suspected to be due to implant surgery.No additional or relevant information has been received to date.

Manufacturer Narrative

Udi #, corrected data: initial report inadvertently listed wrong udi/di number.

Event Description

It was later reported from the patient's neurologist that the patient's caregiver noted a "darkened area the size of a quarter" over the patient's vns generator site.The physician and neurosurgeon examined the darkened area and noted no fever, no drainage, and no signs of infection.The patient later went to the emergency room because the area over the generator had opened and the generator was visible.The device was explanted.System diagnostics were provided indicating no device failure.Follow up with the neurologist's office indicated that the suspected cause of the bruising and the incision site opening up was a pressure sore from the patient's chin that eventually opened up.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• 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: 7205818
• MDR Text Key: 97751442
• Report Number: 1644487-2018-00111
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/09/2017
• Device Model Number: 104
• Device Lot Number: 203318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/19/2015
• 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: 55 YR