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 Unspecified Infection (1930); Nerve Damage (1979)

Event Date 07/25/2018

Event Type  Injury  

Event Description

It was reported that a vns patient was in the emergency room most of the night and would have the vns explanted due to infection.Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution.Additional relevant information has not been received to-date.

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy but related to the implanting procedure.

Event Description

An update was received indicating that the vns generator was explanted and the lead was left in place.However, the infection did not resolve and was spreading to the neck site, so the lead was later explanted as well.It was further noted that during the lead explant procedure, the surgeon had inadvertently cut the vagus nerve and had to repair it.No additional relevant information was received to date.

Manufacturer Narrative

Patient problem codes.Corrected data.Previous reports inadvertently did not capture nerve damage in the patient coding.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7825641
• MDR Text Key: 118524954
• Report Number: 1644487-2018-01516
• 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,Followup
• Report Date: 12/04/2018

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: 05/15/2020
• Device Model Number: 1000
• Device Lot Number: 204502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 10/15/2018; 11/09/2018
• Supplement Dates FDA Received: 11/09/2018; 12/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2018
• 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: 9 YR