MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN 106; GENERATOR

Model Number 106

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

Patient Problems Dyspnea (1816); Pain (1994); No Code Available (3191)

Event Date 11/09/2016

Event Type  Injury  

Event Description

Clinic notes from (b)(6) 2016 indicated that the patient was having voice alteration with stimulation.On (b)(6) 2017, it was reported that the patient was experiencing discomfort so she wanted to be referred to a surgeon for evaluation.In clinic notes, the pain was noted to be severe and to be "foreign body pain." the patient was being prescribed percocet then hydrocodone for pain management.In (b)(6) of 2018, the patient reported that she continued to have voice alteration, shortness of breath, and pain, so she wanted to be referred to a surgeon for explant.Information was received from a hospital that the patient had been referred for potential explant.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

It was reported that the patient's vns was referred for explant due to pain.Per the physician, this surgery would be for patient comfort and not to preclude a serious injury.The patient's generator was reportedly turned off.No known surgical intervention has occurred to date.No further relevant information has been received to date.

• Brand Name: PULSE GEN 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: 7768510
• MDR Text Key: 116611083
• Report Number: 1644487-2018-01361
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2018

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: 05/27/2018
• Device Model Number: 106
• Device Lot Number: 4921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2016
• 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: 28 YR