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 Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 12/13/2017

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 a vns patient was scheduled for explant of the generator and lead.The reason was later provided from the notes that it was because the vns incision has opened and is draining pus.Review of the manufacturing records for the generator and lead confirmed the devices were sterilized prior to distribution.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Clinic notes were later received providing that the device had been removed due to the infection on (b)(6) 2018.

Manufacturer Narrative

Date of event, corrected data: the event date was inadvertently provided incorrectly on the initial report.Event description, corrected data: the date of explant was inadvertently provided incorrectly on the event description in follow-up report#1.

Event Description

Clinic notes were received providing that the device had been removed due to the infection on (b)(6) 2018.

• 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: 7287555
• MDR Text Key: 100642924
• Report Number: 1644487-2018-00257
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/22/2019
• Device Model Number: 106
• Device Lot Number: 5386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2017
• 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: 35 YR