MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Syncope (1610); Low Blood Pressure/ Hypotension (1914)

Event Date 07/09/2018

Event Type  Injury  

Event Description

It was reported that a vns patient was experiencing cardiac syncope.The syncope was provided to be mild.The relationship to the implant procedure or vns stimulation is unknown and the adverse event had not resolved at the time of the report.The stimulation was not turned on at the time of the event.Additional relevant information has not been received to-date.

Event Description

Follow-up received indicated it was recommended for the patient to have a blood and heart check and a neurological consultation.The syncope was still ongoing.

Event Description

It was reported that the syncope resolved.The adverse event did not cause the subject to be discontinued from the study.

Event Description

Follow up revealed that the symptoms reported by the patient were between syncope and orthostatic dysfunction.The event was not verified as there was no physician in regards to this.No treatment for the symptoms had occurred.The patient could not provide any further information and, per the facility, the event did not meet serious adverse event (sae) criteria as there was no serious deterioration of health and no medical/surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.The event was corrected to "orthostatic dysfunction", which occurs when the blood pressure drops significantly as the patient stands up, causing lightheadedness, fainting, and heart palpitations, as it seemed to the facility to fit more in what is expected as an ae.

Event Description

It was reported that the patient's treatment with the study device had been modified as a result of the syncope.

• Brand Name: PULSE GEN MODEL 103
• 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: 7809373
• MDR Text Key: 118005186
• Report Number: 1644487-2018-01469
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/11/2019

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: 02/01/2020
• Device Model Number: 103
• Device Lot Number: 204417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 09/13/2018; 10/17/2018; 10/02/2019; 11/18/2019
• Supplement Dates FDA Received: 10/03/2018; 11/06/2018; 10/17/2019; 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• 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): Other
• Patient Age: 60 YR