MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

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

Event Date 09/14/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

Event Description

It was reported that the patient's incision site had come open and the patient had an infection.The patient was referred for surgery.A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution.Follow up with the company representative revealed that the vns generator site incision had opened and the vns lead was visible.It was reported that the patient underwent surgery.The surgeon cleaned up the infected area, then put the vns back in, and closed the patient.No additional relevant information has been received to date.

Event Description

The operative report from the previous vns generator replacement surgery were received by the manufacturer.The operative report indicated that the left chest was prepped and draped in sterile fashion.The previous vns generator incision site was open and the previous generator was disconnected from the vns lead and removed.The wound was irrigated.The new vns generator was connected to the vns leads and then placed back into the previous generator's pocket.The wound was closed with interrupted 2-0 vicryl and followed by a steri-strip closure of the skin.There were no complications reported.

Event Description

It was reported that the patient underwent vns explant surgery.Follow up with the surgeon's office revealed that the it look as if part of the patient's vns was sticking out of the patient's body like her body was rejecting it.The patient was reported to have continued drainage from both sites and had been on iv antibiotics.The vns was explanted due to the continued infection.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6966095
• MDR Text Key: 89865302
• Report Number: 1644487-2017-04650
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/25/2019
• Device Model Number: 106
• Device Lot Number: 204089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2017
• 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: 31 YR