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 Problem Unspecified Infection (1930)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The nurse reported that a patient had both vns generator and lead explanted due to a badly infected wound site.The nurse stated that the infection was present at both generator site and lead site.The patient has had several infections including a previous vns explant due to infection, captured in mfr report # 1644487-2018-00994, and an infection that lead to an above the knee amputation.Therefore, the patient was seen by an immunologist to ensure there were no underlying factors causing these infections and none were evident.Device history records were reviewed and showed that the implanted generator and lead were sterilized prior to distribution.All other quality tests also passed prior to distribution.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No other relevant information has been received to date.

Manufacturer Narrative

Report source, corrected data: initial mdr inadvertently listed wrong report source.

• 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: 8338649
• MDR Text Key: 136111720
• Report Number: 1644487-2019-00287
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2020
• Device Model Number: 1000
• Device Lot Number: 005905
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2018
• 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: 58 YR