MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Scarring (2061); Impaired Healing (2378)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the patient's neurologist that the patient was seen by their neurosurgeon due to the possible "rejecting" of the vns and granulation tissue at both incision sites.The neurosurgery team was reportedly not adamant that the vns would need to be removed.A review of the device history records was performed and both implanted products were sterilized per labeling and passed all functional specifications and quality tests prior to distribution.No surgical intervention regarding this event has been known to have occurred to date.No additional relevant information has been received to date.

Manufacturer Narrative

Patient code - correction - inadvertently coded scarring in initial mdr submitted.Allergic reaction is best suited for the event of granulation tissues instead of scarring in which there has been no known intervention to have occurred to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 8901018
• MDR Text Key: 154544718
• Report Number: 1644487-2019-01586
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 09/10/2019

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: 12/04/2020
• Device Model Number: 1000
• Device Lot Number: 204751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2019
• 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): Other
• Patient Age: 8 YR