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

Model Number 104

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

Patient Problem Unspecified Infection (1930)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.

Event Description

It was reported that the patient had an incision and drainage procedure with chest would debridement.The vns generator site was infected with green drainage and wires and hardware from the vns were exposed.Device history records were reviewed for the generator.The device was sterilized and passed all specifications prior to distribution.The patient¿s infection was believed to be related to a previous infection, reported in mfr.Report 1644487-2018-01176.This infection is being reported separately as it occurred on a new generator.Information was received that the patient was continuing to reopen his wound.The patient had the sutures removed, and the wound had reopened.The patient was doing well and the site was clean with no drainage.The patient is on antibiotics.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No additional surgical intervention has occurred to date.No additional or relevant information has been received to date.

Manufacturer Narrative

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

Event Description

The patient was explanted.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No additional or relevant information has been received to date.

Manufacturer Narrative

Describe event or problem; corrected data: initial mdr inadvertently did not mention the patient¿s drainage.

Event Description

It was reported that the patient had purulent drainage from the vns site.

• 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: 8449326
• MDR Text Key: 139748071
• Report Number: 1644487-2019-00517
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Model Number: 104
• Device Lot Number: 204429
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2018
• 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