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

Model Number 106

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

Patient Problems Hiccups (1899); Convulsion, Clonic (2222); Cough (4457)

Event Date 03/08/2022

Event Type  Injury  

Event Description

The patient's mother reported that the patients vns battery is low and she is having increased coughing, hiccups, and seizures.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Manufacturer Narrative

B2.Corrected information, initial report: inadvertently did not select hospitalization.B5.Corrected information, initial report: inadvertently did not report the hospitalization due to seizures.F10.Corrected information, initial report: inadvertently did not use code f08 for hospitalization.

Event Description

The patients mom reported that the patient was hospitalized after having up to 20 seizures.The patients generator was replaced.The explanted generator has not been received to date.Information was received from the physician that the increase in seizures was back to pre-vns levels and was related to low battery.The coughing and hiccups were also believed to be due to low battery, and the replacement referral was for patient comfort only per the physician.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 13978484
• MDR Text Key: 288396542
• Report Number: 1644487-2022-00368
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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: 03/01/2019
• Device Model Number: 106
• Device Lot Number: 204067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female