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 Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 12/01/2019

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 originally reported in mfr report # 1644487-2018-01588 that a patient had an infection.Additional information was received that the infection was at the generator site and unrelated to the events in mfr report # 1644487-2018-01588 therefore all information regarding the generator infection will be housed in this report.The patient had a revision then was prescribed antibiotics and eventually had a full explant.The recent infection was not a continuation of the patient¿s past extrusion event and that the location of the patient¿s infection was at the generator site.The physician¿s assessment on the cause of the infection was that it was due to persistent protrusion of the battery.Device history records indicated both devices were confirmed to be hp sterilized prior to distribution.No additional information has been received to date.

Event Description

Information was received that the believed cause of the protrusion was due to the placement of the device.

Manufacturer Narrative

If explanted, give date (mo/day/yr), explant date was inadvertently omitted from the initial mdr.

• 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: 8444571
• MDR Text Key: 139583501
• Report Number: 1644487-2019-00575
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2016
• Device Model Number: 104
• Device Lot Number: 4004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2014
• 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: 73 YR