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 Edema (1820); Fluid Discharge (2686)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary as the swelling and drainage is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that following vns implant surgery, the patient presented with some swelling and discharge at the generator site.The patient was prescribed a prophylactic antibiotic.Attempts for further information have been made; no additional relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

A review of device history records showed that both the lead and generator were sterilized prior to distribution.No unresolved nonconformances were noted prior to distribution.No additional 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9750559
• MDR Text Key: 180748694
• Report Number: 1644487-2020-00325
• 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: 02/25/2020

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: 06/05/2021
• Device Model Number: 106
• Device Lot Number: 6312
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2019
• 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: 30 YR