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

Model Number 104

Device Problem No Display/Image (1183)

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

Event Date 12/01/2016

Event Type  Injury  

Event Description

It was initially reported that there was concern about the patient's generator site.Additional information was received that the generator was extruding from the site and was visible.This was stated to be caused by an ongoing infection at the generator site that initially occurred during the patient's vns replacement surgery.There was an abscess that was draining at the site and topical antibiotics were prescribed.The patient was referred for surgery to address the issue and possibly explant the vns device.A review of device history records showed that both the lead and generator were sterilized prior to distribution.No surgical intervention is known to have occurred to date.No additional relevant information has been received to date.

Manufacturer Narrative

Device evaluation is not necessary because the reported infection has been determined as not related to vns therapy but rather the vns surgery.Explanted date: corrected information - in the initial report the explant date should have been included as the device had been explanted at the time of the report.

Event Description

The patient's generator was explanted due to the infection.A new generator was reimplanted at a later date.The medical professional for the patient mentioned that there was a possibility of the patient picking at the implant site causing the infection however this was just a possibility with no confirmation.

Event Description

Additional information was received the patient had an infection and the current implanted vns device was extruding.These events for the patient are reported in med watch # 1644487-2019-00517.The infection and extrusion events were attributed to the previous infection and extrusion reported in this med watch.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7686293
• MDR Text Key: 113933221
• Report Number: 1644487-2018-01176
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2018
• Device Model Number: 104
• Device Lot Number: 203896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2016
• 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: 53 YR