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 08/03/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported by the neurologist that a young patient, who had been implanted earlier the previous month had been explanted due to infection.The neurologist believed it was related to the sterile field in the operation room.The manufacturer's device history records of the patient's lead and generator were reviewed.Sterility prior to distribution was verified.No further relevant information has been received to date.

Event Description

It was reported that in the pre-operative explant notes it was indicated that the patient had reportedly picked part of the generator site open.The surgeon's office indicated that surgery occurred after (b)(6) 2017 but that by (b)(6) 2017 both the lead and generator were removed and the sites were healing well.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: 6950577
• MDR Text Key: 89358656
• Report Number: 1644487-2017-04609
• 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,Followup
• Report Date: 11/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Model Number: 106
• Device Lot Number: 204027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/15/2017
• Supplement Dates Manufacturer Received: 11/03/2017; 06/19/2018
• Supplement Dates FDA Received: 11/19/2017; 06/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2017
• 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: 4 YR