MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069)

Event Date 12/14/2017

Event Type  Injury  

Event Description

It was reported that the patient was feeling pain in her chest and could feel her device move when she moved her arm.The patient was referred for generator repositioning surgery due to the pain and migration.The patient had surgery, and the generator was still sutured down in place from the implant surgery.The surgeon identified a mass of fluid around and below the generator.The seroma was drained, and the surgeon prescribed antibiotics.The generator was left in place, and the lead was not disconnected.Diagnostics were within normal limits, and the settings were not changed.The surgeon reported that the seroma caused an infection at the generator site.No further relevant information has been received to date.

Manufacturer Narrative

Device evaluated by mfr? - device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

The patient was later referred for generator removal as the seroma had not gone away and was causing severe pain, even after a long course of antibiotics.There was no erythema or fever, but the fluid collection did not go down.The patient had generator explant surgery due to the seroma and pain.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7404008
• MDR Text Key: 104599922
• Report Number: 1644487-2018-00535
• 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
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• 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: 05/31/2018
• 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: 45 YR