MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Paralysis (1997)

Event Date 01/01/2016

Event Type  Injury  

Event Description

It was reported that the patient's device was disabled some time ago due to shortness of breath with stimulation and vocal cord paralysis.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

Information was received from the physician that the vocal cord paralysis first began in 2016.The cause of the vocal cord paralysis and dyspnea was due to vns stimulation per the physician.No further relevant information has been received to date.

Event Description

Additional information was received that the patient also had their device disabled due to the device causing their blood pressure to drop.No other relevant information has been received to date.

Event Description

Update was received from the patient that the vns was explanted.The suspect device has not been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 11798021
• MDR Text Key: 249721018
• Report Number: 1644487-2021-00635
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/02/2024

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: 06/14/2015
• Device Model Number: 105
• Device Lot Number: 3676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 05/25/2021; 06/21/2023; 09/07/2024
• Supplement Dates FDA Received: 06/14/2021; 07/13/2023; 10/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2013
• 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: 52 YR
• Patient Sex: Female